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

Healthy Clinical Trial

Official title:

A Phase 1, Single and Multiple Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 Injection in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308940
• Other study ID #: TB001CT0001
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2022
• Est. completion date: August 23, 2022

Study information

• Verified date: April 2023
• Source: Shenzhen Turier Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TB001
once-daily subcutaneous injection, on Day 1 in SAD stage
• TB001
once-daily subcutaneous injection, on Days 1-7 in MAD stage
• Placebo
once-daily subcutaneous injection, on Day 1 in SAD stage
• Placebo
once-daily subcutaneous injection, on Days 1-7 in MAD stage

Locations

Country	Name	City	State
China	Shenzhen Turier Biotech Co., Ltd.	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Turier Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AEs)	An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.	Day 1 and up to Day 28
Secondary	Pharmacokinetics exposure of TB001 in SAD and MAD stage	Serum concentrations of TB001 at different timepoints before and after TB001 administration.	Day 1 , Day 7
Secondary	Observed immunogenicity of TB001 in MAD stage	Number of subjects who develop detectable ADAs and NAb after TB001 administration.	Day 1, Day 7, Day 14, Day 28