A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects

NCT05409326 | Unknown Phase 1

• 1 other identifier: TQH2722-I-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (19)

• Adverse events (AE)

  Incidence and severity of adverse events (AE) .

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Serious adverse events (SAE)

  Incidence and severity of Serious adverse events (SAE).

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Blood biochemistry

  Abnormal indicators of blood biochemistry.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Coagulation function

  Abnormal indicators of coagulation function.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Blood routine

  Abnormal indicators of blood routine.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Urinalysis

  Abnormal indicators of urinalysis.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Blood pressure

  Abnormal values of blood pressure

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Pulse

  Abnormal values of blood pulse.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Body temperature

  Abnormal values of blood body temperature.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Skin

  Examination of the skin.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Mucous membranes

  Examination of the mucous membranes.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Lymph nodes

  Examination of the lymph nodes.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Head

  Examination of the head.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Neck

  Examination of the neck.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Chest

  Examination of the chest.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Abdomen

  Examination of the abdomen.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Spine

  Examination of the spine.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• Limbs

  Examination of the limbs.

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

• 12-lead electrocardiogram

  Abnormal values of 12-lead electrocardiogram

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.

Secondary Outcomes (12)

• Maximum Concentration（Cmax）

  SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.

• Minimum Concentration(Cmax)

  SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.

• Time to maximum concentration(Tmax)

  SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.

• Area under the drug-time curve(AUC)

  SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.

• Apparent terminal elimination half-life(t1/2)

  SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.

Study Arms (2)

TQH2722 injection

EXPERIMENTAL

Participants will receive single dose of TQH2722 injection under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of TQH2722 injection once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.

Drug: TQH2722 injection

Placebo to match TQH2722

PLACEBO COMPARATOR

Participants will receive single dose of matching placebo under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of matching placebo once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.

Drug: Placebo to match TQH2722

Interventions

TQH2722 injection DRUG

TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.

TQH2722 injection

Placebo to match TQH2722 DRUG

TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.

Placebo to match TQH2722

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The informed consent was signed before the trial, fully understood the purpose and process of the trial and the possible adverse reactions.
• Aged 18 \~ 60 years old (including the critical value), both male and female;
• ≥ 45 kg for females and ≥ 50 kg for males with a body mass index (BMI) between 19 and 26 kg/m2 inclusive, BMI = weight (kg)/height2 (m2)
• The subject is able to communicate well with the investigator, voluntary and able to understand and follow protocol procedures to complete the study;
• The subject agrees not to have a childbearing plan from the date of signing the informed consent form to 6 months after the last dose, and must use effective non-drug contraception with a partner of childbearing potential;
• Normal physical examination, vital signs or abnormal physical examination, vital signs without clinical significance

You may not qualify if:

• Females who are pregnant, lactating or have unprotected sex within two weeks prior to screening;
• Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
• People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, eye examination, 12-lead ECG and X-ray during screening period;
• Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP);
• Clinically significant respiratory infection requiring antibiotic or antiviral therapy within 7 days prior to randomization;
• People who received surgical operation within 4 weeks prior to screening, or planned to receive surgical operation during the study period;
• People who participated in other clinical trials and took the study drug within 3 months before screening;
• Received immunoglobulins or blood products within 30 days prior to randomization;
• Blood loss or blood donation of more than 400 mL within 2 months prior to randomization;
• People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness;
• A history of allergic reactions to another therapeutic monoclonal antibody or biologic agent therapy, or any clear history of drug or food allergies, particularly those with allergies to similar components to the drug in this trial;
• People who have received or are planning to receive live-reduced or active vaccines during the 30 days prior to randomization and the entire study period (including the follow-up period);
• Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products during the 6 months prior to randomization and the entire study period (including the follow-up period);
• People who had long-standing alcohol abuse or alcohol consumption of more than 14 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week during the 3 months prior to screening and the entire study period (including the follow-up period), or those who tested positive for alcohol breath;
• People with a history of substance abuse or positive urine drug screening;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Yu Cao, Doctor

CONTACT

0532-82917310; caoyu1767@126.com

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 8, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

CN (1)