First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036

NCT04993443 | Terminated Phase 1

• 1 other identifier: LQ036A001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This is Phase I first-in-human trial evaluating the safety, tolerability, immunogenicity, and pharmacogenomics of LQ036 via inhalation and IV infusion. The study will be divided into 4 parts: Single Ascending Dose, Multiple Ascending Dose, and Intra Venous with a target of 88 healthy volunteers and 30 patients with mild Asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (49)

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of outcome of Adverse events

  Up to 5 weeks.

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Abnormal blood pressure Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1. Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.

  Up to 1 Month

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Abnormal pulse rate Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1. Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.

  Up to 1 Month

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Abnormal respiratory rate Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1. Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.

  Up to 1 Month

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Abnormal Tympanic Temperature Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1. Part B and D: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.

  Up to 1 Month

• To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.

  Change in electrocardiograms (ECGs). Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 8, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1. Part B and D: At check-in (Day -1), and pre-dose and 1, 2, and 8 hours post-dose on Days 1 to 12, and at discharge (Day 13), and on Days 15±1, 22±1, and 29±1.

  Up to 1 Month

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (hemoglobin) Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1). Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (hematocrit) Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1). Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (mean corpuscular volume) Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1). Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (leukocyte counts) Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1). Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (platelet count) Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1). Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (Urea) Part B and D: At check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1). Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (creatinine)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (alkaline phosphatase)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (glucose)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (alanine aminotransferase (ALT))

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (aspartate amino transferase (AST))

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (total bilirubin)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (sodium)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (potassium)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (chloride)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (calcium)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (total proteins)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (Phosphorus)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (albumin)

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (Coagulation test (aPTT (Activated partial thromboplastin time) and INR (International Normalized Ratio)) Part B and D: At screening and at study exit (Day 36±1) Part A and C: At screening and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Assessment of abnormal clinical laboratory tests (Urine macroscopic examination, pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, nitrite, urobilinogen, and leukocytes) Part B and D: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1). Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), and at study exit (Day 29±1).

  Up to 5 Weeks

• To evaluate the tolerability of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Local tolerability (oropharyngeal) assessment (Part A) and (injection site) assessment (Part C): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness. Time frame: pre-dose, Day 1, 2, 4, 8, and 24 hours post-dose, and at Day 3. Local tolerability (oropharyngeal) assessment (Part B and D): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness. Time frame: pre-dose (as well as 1, 2, and 4 hours post-dose on Days 1, 3, 5, 8, and 10, 11, 13, and at day 36.

  Up to 5 weeks

• To evaluate the immunogenicity of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Immunogenicity data that will be evaluated include Anti-Drug Antibody test sampling (ADA). Parts A and C: A total of 5 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, and 22±1, and at study exit (Day 29±1) Part B and D: A total of 6 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, 22±1, 29±1, and at study exit (Day 36±1)

  Up to 5 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.

  AUC0-t: Area under the concentration-time curve from time zero until the last observed concentration

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.

  AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated)

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.

  Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-t/AUC0-inf)\] x 100

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  AUC0-24: Area under the concentration-time curve from time zero to 24 hours post-dose.

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  AUC0-τ: Area under the concentration-time curve for one dosing interval (τ) at steady-state. In this study τ = 24 hours (AUC0-24)

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  AUC0-72: Area under the concentration-time curve from time zero to 72 hours post-dose.

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Cmax: Maximal observed concentration

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Cmax ss: maximum observed concentration at steady-state

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Cmin ss: minimum observed concentration at steady-state

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Tmax ss: time of observed Cmax at steady-state

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Tmax: Time of Cmax

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects

  T½ el: Terminal elimination half-life

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (Kel)

  Kel: Terminal elimination rate constant

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma (Racc)

  Racc: drug accumulation ratio

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma. (PTF%)

  PTF%: peak trough fluctuation

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects.

  Cl/F: Apparent body clearance, calculated as Dose / AUC0-inf

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects

  Vd/F: apparent volume of distribution, calculated as Dose / Kel \* AUC0-inf

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Clss/F: apparent body clearance at steady-state, calculated as dose / AUC0-inf

  Up to 2 Weeks

• To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects and patients with mild Asthma.

  Vdss/F: apparent volume of distribution at steady-state, calculated as dose / (Kel \* AUC0-inf)

  Up to 2 Weeks

• To evaluate the change in fraction exhaled nitric oxide (FeNO) after multiple doses of LQ036 administered via inhalation in patients with mild asthma.

  At screening, on dosing days (Days 1 to 10, within 60 minutes prior to dosing), on Days 11, 12, and at discharge (Day 13), as well as on Days 15±1, 22±1, 29±1, and at study exit (Day 36±1).

  Up to 6 weeks

Secondary Outcomes (8)

• To compare the PK of LQ036 after administration via inhalation and IV routes

  Up to 2 weeks

• To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (AUC0-24 versus AUC0-τ)

  Up to 2 weeks

• To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Cmax versus Cmax ss)

  Up to 2 weeks

• To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Tmax versus Tmax ss)

  Up to 2 weeks

• To compare the PK of LQ036 after administration via inhalation in healthy subjects versus patients with mild asthma.

  Up to 2 weeks

Study Arms (2)

Active Comparator: Drug :LQ036

EXPERIMENTAL

Experimental, Single and Multiple Oral escalating dose

Drug: LQ036

Placebo Comparator: Matching Placebo for LQ036

PLACEBO COMPARATOR

Matching Placebo for LQ036: Matching Placebo

Other: Matching Placebo

Interventions

LQ036 DRUG

For Each part of the study, a staggered dosing schedule may be used for the first dose level, in each cohort including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects for Part A-C and 8 subjects for Part D initiating dosing no sooner than the next day. Each study part (A, B, C, and D) will be completed sequentially, but with partial overlapping. Part B and C may only be initiated after review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4. Part D may be initiated when safety tolerability and PK data are known and deemed acceptable by the SRC for multiple doses in Part B, at least at the same concentration to be administered in Part D.

Active Comparator: Drug :LQ036

Matching Placebo OTHER

Matching Placebo for LQ036: Matching Placebo

Also known as: Matching Placebo for LQ036

Placebo Comparator: Matching Placebo for LQ036

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• the absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory (except resolved childhood asthma), hematological, immunological, psychiatric (except including depression that has not required treatment for at least 6 months), gastrointestinal, renal, hepatic, and metabolic disease.
• Male or female, non-smokers or casual smokers (defined as smoking the equivalent of less than an average of 5 cigarettes per week over a 3 month period, and willing to abstain from smoking during involvement in the study and for 1 month prior to screening), ≥18 and ≤55 years of age, with BMI \>18.0 and \<32.0 kg/m2.
• Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
• Simultaneous use of intrauterine device placed at least 4 weeks prior to study drug administration, and condom for the male partner;
• Simultaneous use of hormonal contraceptives started at least 4 weeks prior to study drug administration and condom for the male partner.
• Sterile male partner (vasectomized since at least 6 months).
• Male subjects who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
• Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks, or intra-uterine contraceptive device placed since at least 4 weeks;
• Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
• Subjects with normal lung function defined as greater than or equal to 80% predicted forced expiratory volume in one second (FEV1).
• Males and females who are in same-sex relationships can be included. There are no mandatory contraceptive requirements for males or females in same-sex relationships.
• Male and female heterosexual subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle.
• Part D only: Volunteers with mild asthma defined as:

You may not qualify if:

• Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found at screening or at check-in (Day -1, not applicable to serology assessments).
• Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of check-in, or planned inpatient surgery or hospitalization during the study period.
• Any history of malignancy or neoplastic disease (not including excised, non-recurrent, non-melanoma skin cancers).
• Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or at check-in (Day -1).
• History of allergic reactions to LQ036, to any biologic therapy, or other related drugs, or to any excipient in the formulation.
• Positive pregnancy test at screening or at check-in (Day -1)
• Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure less than 90 or greater than 140 mmHg, diastolic blood pressure less than 40 or greater than 90 mmHg, or heart rate less than 40 or greater than 100 bpm) at screening.
• History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit. Regular use of alcohol is defined as greater than 14 units of alcohol per week, where 1 unit is defined as 100 mL of wine at 13.5% a/v, 375 mL of beer at 3.5% a/v, or 30 mL of spirit at 40% a/v.
• History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as tetrahydrocannabinol) within 1 month prior to the screening visit or hard drugs (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, and phencyclidine) within 3 months prior to screening.
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
• Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
• Prescription medications (except for hormonal contraceptives in all study parts and short-acting β2 agonists for patients in Part D) within 14 days prior to the first dosing;
• Over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing, with the exception of the occasional use of paracetamol/acetaminophen (up to 2 g daily), ibuprofen (up to 800 mg daily), and oral contraceptives;
• Depot injection or implant (except for hormonal contraceptives) of any drug within 3 months prior to the first dosing;
• Long-acting ß2 agonists for 4 weeks prior to screening;

Sponsors & Collaborators

• Syneos Health: lead
• Shanghai Novamab Biopharmaceuticals Co. Ltd.: collaborator

Study Sites (2)

Q-Pharm Pty Ltd (Nucleus Network Brisbane)

Brisbane, Queensland, 4006, Australia

Location

Nucleus Network Melbourne

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Huaiyu Gu

  Shanghai Novamab Biopharm Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: August 6, 2021
• Study Start: September 6, 2021
• Primary Completion: March 2, 2023
• Study Completion: March 9, 2023
• Last Updated: April 13, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)