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A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

Primary Purpose

Chronic Hepatitis b

Status

Not yet recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

TQA3038 injection

TQA3038 injection matching placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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；

Sites / Locations

Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TQA3038 injection

TQA3038 injection matching placebo

Arm Description

One dose of TQA3038 injection in Day 1.

One dose of TQA3038 injection matching placebo in Day 1.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax)

Maximum concentration of TQA3038 and its metabolite in plasma

Time to Reach Maximum Plasma Concentration (Tmax)

Time to reach Cmax of TQA3038 and its metabolite in plasma

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

Apparent Terminal Elimination Half-life (T1/2)

Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma

Apparent Plasma Clearance (CL/F)

Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma

Fraction eliminated in the urine

Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma

Full Information

NCT ID

NCT06085053

First Posted

October 11, 2023

Last Updated

October 17, 2023

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT06085053

Brief Title

A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis b

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TQA3038 injection

Arm Type

Experimental

Arm Description

One dose of TQA3038 injection in Day 1.

Arm Title

TQA3038 injection matching placebo

Arm Type

Placebo Comparator

Arm Description

One dose of TQA3038 injection matching placebo in Day 1.

Intervention Type

Drug

Intervention Name(s)

TQA3038 injection

Intervention Description

TQA3038 is an injection.

Intervention Type

Drug

Intervention Name(s)

TQA3038 injection matching placebo

Intervention Description

Placebo injection contains no active substance.

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Description

Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time Frame

Up to 85 days.

Title

Number of subjects with clinically significant abnormalities

Description

Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

Time Frame

Up to 85 days.

Secondary Outcome Measure Information:

Title

Maximum Plasma Concentration (Cmax)

Description

Maximum concentration of TQA3038 and its metabolite in plasma

Time Frame