Single and Multiple Doses of HA115 and Food Effect in Healthy Adult Volunteers

NCT03567694 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: CSPC-HA115-US-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled Phase 1 study of HA115 capsules administered orally to healthy adult volunteers.

Conditions

Asthma

Keywords

asthma, allergic rhinitis, HA115, CRTH2 antagonists; CT133

Outcome Measures

Primary Outcomes (1)

• Adverse event (AE)

  Percentage of subjects experiencing adverse event (AE).

  36 days

Study Arms (2)

Single Ascending Dose and Food effect

EXPERIMENTAL

This is the SAD / Food effect arm. For SAD, a total of 80 subjects will be enrolled into 8 groups of 10 subjects each; within each group, 8 will receive HA115 at a single ascending dose 10, 25, 50, 100, 200, 400, 800, 1200 mg, and 2 subjects will be placebo control. For food effect study,10 participants will be administered HA115 at a single dose to be selected based on SAD results.

Drug: HA115; Drug: Placebo

Multiple Ascending Dose

EXPERIMENTAL

For the MAD portion, 3 dose levels will be selected based on SAD results.

Drug: HA115; Drug: Placebo

Interventions

HA115 DRUG

Test Drug

Multiple Ascending Dose; Single Ascending Dose and Food effect

Placebo DRUG

Placebo

Multiple Ascending Dose; Single Ascending Dose and Food effect

Eligibility Criteria

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

You may qualify if:

• Healthy males or females, 18-55 year old, inclusive, with body mass index (BMI) between 18 and 30 kg/m2, inclusive, and body weight not less than 50 kg.
• In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG, and clinical laboratory tests).
• with normal cardiac conduction and function at screening
• Nonsmoker within the previous 6 months (before screening), and does not use tobacco containing, or nicotine-containing products
• Has normal clinical chemistry, hematology, coagulation, and complete urinalysis (fasted for at least 8 hours) results at screening and Day -1
• Has a negative urine drug screen result at screening and on Day -1.
• For all female participants, have a negative urine pregnancy test at screening and on Day -1, and must not be breastfeeding. Female participants of childbearing potential must agree to use a protocol-approved method of non-hormonal contraception as detailed in Appendix 4 from signing of the informed consent, throughout the duration of the study and for 30 days after the last dose of study drug.
• Male participants who are nonsterilized and sexually active with a female partner of childbearing potential must agree to use a protocol-approved method of non-hormonal contraception as detailed in Appendix 4 from signing of the informed consent, throughout the duration of the study and for 30 days after the last dose of study drug.
• Male participants must agree to not donate sperm during the study and for 3 months (90 days) after receiving the last dose of study drug.

You may not qualify if:

• Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the investigator considers should exclude the participant, or that could interfere with the interpretation of the study results.
• Has current or recent (within 6 months) history of gastrointestinal disease (except for appendectomy, inguinal/umbilical hernia), or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drugs.
• Has any clinically significant medical condition, physical examination finding, ECG abnormality, or clinically significant abnormal value for clinical chemistry, hematology, coagulation, or urinalysis at Screening or at admission to the study center, as deemed appropriate by the investigator.
• Has any of the following (participant may rescreen once for failure to meet criteria at Screening):
• SBP \>150 mmHg at Screening stable (measured in supine position)
• DBP of \>95 mmHg at Screening stable (measured in supine position).
• History or presence of malignancy within the past 5 years, except for adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
• Currently suffers from clinically significant systemic allergic disease, or has a history of significant drug allergies, including but not limited to:
• A history of anaphylactic reaction
• Allergic reaction due to any drug that led to significant morbidity
• Known hypersensitivity to any component of the formulation of HA115.
• Has donated blood or had an acute loss of blood (\>500 mL) during the 3 months before study drug administration or intends to donate blood or blood products within 3 months after the completion of the study.
• Has had an acute, clinically significant illness within 30 days prior to Day 1, or has had a recent febrile illness with an abnormal body temperature for at least 72 hours before dosing on Day 1.
• Has a history (within the past 12 months before Screening) of drug abuse (defined as any illicit drug use), or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week), or a positive test for drugs of abuse at Screening or upon admittance to the testing facility (Day -1) or is unwilling to abstain from alcohol and drugs of abuse throughout the study.
• Has a smoking history during the past 6 months before Screening. This includes the use of any nicotine containing substances (e.g., nicotine patch or gum, chewing tobacco, e cigarettes), or has a positive cotinine test at Screening or Day -1, or is unwilling to abstain from these products for the duration of the study.

Sponsors & Collaborators

• Conjupro Biotherapeutics, Inc.: lead

Study Sites (1)

CNS Network

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Officials

  Conjupro Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, principal investigator, and all other study personnel involved with participant assessments will remain blinded to the actual treatment assignments of the participants. The principal investigator will be ultimately responsible for ensuring that the integrity of the blind is maintained throughout the study and will be required to notify the sponsor in the event of any breaking of the blind for any reason. An unblinded pharmacist staff will be required at the Clinical Site to comply with the study's randomization and blinding requirements. At the Clinical Site, prior to study initiation, the principal investigator will be responsible for designating a qualified pharmacy staff to serve as the unblinded pharmacy staff in the study. Unblinded pharmacy staff may not participate in any participant assessments.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of 2 parts, Part A (SAD, including fed/fasted comparison) and Part B (MAD). Part A will include an assessment of the effect of a high-fat breakfast on the absorption and PK profile of HA115, performed in 10 participants at a single dose to be selected based on SAD results and predicted to be associated with therapeutic plasma concentrations. Part B will be a randomized, double-blind, placebo controlled parallel group study of up to 3 dose levels of HA115 given once daily. The number of days of dosing will be based on the results of the PK analysis from Part A. In each cohort, 8 participants will receive active compound fasted and 2 will receive placebo in a randomized, double blind fashion. Safety observations and PK evaluations will be made. Safety data will be reviewed with the SRC prior to each dose escalation.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 26, 2018
• Study Start: October 1, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 12, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)