A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06085053
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 2.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b	Drug: TQA3038 injection; Drug: TQA3038 injection matching placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TQA3038 Injection in Healthy Adult Subjects.
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TQA3038 injection One dose of TQA3038 injection in Day 1.	Drug: TQA3038 injection; TQA3038 is an injection.
Placebo Comparator: TQA3038 injection matching placebo One dose of TQA3038 injection matching placebo in Day 1.	Drug: TQA3038 injection matching placebo; Placebo injection contains no active substance.

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events (AEs) and serious adverse events (SAEs) [Up to 85 days.]

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

2. Number of subjects with clinically significant abnormalities [Up to 85 days.]

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

Secondary Outcome Measures

1. Maximum Plasma Concentration (Cmax) [Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose]

   Maximum concentration of TQA3038 and its metabolite in plasma

2. 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]

   Time to reach Cmax of TQA3038 and its metabolite in plasma

3. 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]

   Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time

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

5. Apparent Plasma Clearance (CL/F) [Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose]

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

6. Fraction eliminated in the urine [Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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；

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital	Wuhan	Hubei	China	40030

Sponsors and Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06085053
• Other Study ID Numbers: TQA3038-I-01
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis B; Hepatitis B, Chronic

Study Results

No Results Posted as of Oct 18, 2023