A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

CTTQ

Status and phase: Enrolling; Phase 1

Conditions: Chronic Hepatitis b

Treatments: Drug: TQA3038 injection; Drug: TQA3038 injection matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06085053

TQA3038-I-01

Details and patient eligibility

About

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).

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

TQA3038 injection

Experimental group

Description:

One dose of TQA3038 injection in Day 1.

Treatment:

Drug: TQA3038 injection

TQA3038 injection matching placebo

Placebo Comparator group

Description:

One dose of TQA3038 injection matching placebo in Day 1.

Treatment:

Drug: TQA3038 injection matching placebo