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A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

NCT ID: NCT06085053

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-12-31

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).

Detailed Description

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Conditions

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Chronic Hepatitis b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TQA3038 injection

One dose of TQA3038 injection in Day 1.

Group Type EXPERIMENTAL

TQA3038 injection

Intervention Type DRUG

TQA3038 is an injection.

TQA3038 injection matching placebo

One dose of TQA3038 injection matching placebo in Day 1.

Group Type PLACEBO_COMPARATOR

TQA3038 injection matching placebo

Intervention Type DRUG

Placebo injection contains no active substance.

Interventions

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TQA3038 injection

TQA3038 is an injection.

Intervention Type DRUG

TQA3038 injection matching placebo

Placebo injection contains no active substance.

Intervention Type DRUG

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；
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Liu, Doctor

Role: CONTACT

Phone: +86 13507183749

Email: [email protected]

ZheLong Liu, Doctor

Role: CONTACT

Phone: +86 13986235028

Email: [email protected]

Facility Contacts

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Dong Liu, Doctor

Role: primary

Other Identifiers

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TQA3038-I-01

Identifier Type: -

Identifier Source: org_study_id