A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

Study Overview
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Brief Summary
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This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics. In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).

Official Title
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A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TQA3038 Injection in Healthy Adult Subjects.

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Drug: TQA3038 injection
* Drug: TQA3038 injection matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18～60 years. Body mass index (BMI) 19 - 26 kg/m^2. Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation； History or evidence of drug or alcohol abuse； History of intolerance to SC injection；

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQA3038 injection<br>One dose of TQA3038 injection in Day 1. | Drug: TQA3038 injection<br>* TQA3038 is an injection.<br>|
| Placebo Comparator: TQA3038 injection matching placebo<br>One dose of TQA3038 injection matching placebo in Day 1. | Drug: TQA3038 injection matching placebo<br>* Placebo injection contains no active substance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Up to 85 days. | 
| Number of subjects with clinically significant abnormalities | Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. | Up to 85 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) | Maximum concentration of TQA3038 and its metabolite in plasma | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | 
| Time to Reach Maximum Plasma Concentration (Tmax) | Time to reach Cmax of TQA3038 and its metabolite in plasma | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | 
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | 
| Apparent Terminal Elimination Half-life (T1/2) | Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | 
| Apparent Plasma Clearance (CL/F) | Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | 
| Fraction eliminated in the urine | Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma | Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1. |