A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

NCT06085053 | Unknown Phase 1

• 1 other identifier: TQA3038-I-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Maximum Plasma Concentration (Cmax)

  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)

  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)

  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)

  Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose

• Apparent Plasma Clearance (CL/F)

  Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose

Study Arms (2)

TQA3038 injection

EXPERIMENTAL

One dose of TQA3038 injection in Day 1.

Drug: TQA3038 injection

TQA3038 injection matching placebo

PLACEBO COMPARATOR

One dose of TQA3038 injection matching placebo in Day 1.

Drug: TQA3038 injection matching placebo

Interventions

TQA3038 injection DRUG

TQA3038 is an injection.

TQA3038 injection

TQA3038 injection matching placebo DRUG

Placebo injection contains no active substance.

TQA3038 injection matching placebo

Eligibility Criteria

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

You may qualify if:

• Male or female age 18～60 years.
• Body mass index (BMI) 19 - 26 kg/m\^2.

You may not qualify if:

• 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；

Sponsors & Collaborators

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

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 40030, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dong Liu, Doctor

CONTACT

+86 13507183749; ld_2069@163.com

ZheLong Liu, Doctor

CONTACT

+86 13986235028; liuzhelong@163.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: October 11, 2023
• First Posted: October 16, 2023
• Study Start: November 30, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-10

Locations

CN (1)