A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: TB001

• Registration Number: NCT05308940
• Lead Sponsor: Shenzhen Turier Biotech Co., Ltd

Brief Summary

It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Written and signed informed consent.
2. Aged 18-55 years (inclusive), male or female.
3. BMI within 18.0-28.0 kg/m2 (inclusive).
4. Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
5. Have agreed to take effective contraception measures.

Exclusion Criteria

1. Have any prior clinically serious disease of any system.
2. Known or suspected allergy to the study drug or any of its ingredients.
3. Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
4. History of recurrent or chronic infection within 6 months prior to the first administration.
5. Unable to comply with dietary management during the study period.
6. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-dose of placebo	Placebo	In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1.
Multiple-dose of placebo	Placebo	In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days.
Single-dose of TB001	TB001	In the SAD stage, participants will receive subcutaneous injection of TB001 once on Day 1, planning to ascend from 20 μg, 60 μg，150 μg，300 μg，600μg to 900 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts.
Multiple-dose of TB001	TB001	In the MAD stage, participants will receive subcutaneous injection of TB001 once daily for 7 days, planning to ascend from 60 μg，150ug to 300 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	Day 1 and up to Day 28	An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics exposure of TB001 in SAD and MAD stage	Day 1 , Day 7	Serum concentrations of TB001 at different timepoints before and after TB001 administration.
Observed immunogenicity of TB001 in MAD stage	Day 1, Day 7, Day 14, Day 28	Number of subjects who develop detectable ADAs and NAb after TB001 administration.

Trial Locations

Locations (1)

Shenzhen Turier Biotech Co., Ltd.; 🇨🇳 Shenzhen, Guangdong, China