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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TB001; Drug: TB001; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518122
      • Shenzhen Turier Biotech Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-dose of 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.	Drug: TB001; once-daily subcutaneous injection, on Day 1 in SAD stage; Drug: TB001; once-daily subcutaneous injection, on Days 1-7 in MAD stage
Experimental: Multiple-dose of 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.	Drug: TB001; once-daily subcutaneous injection, on Day 1 in SAD stage; Drug: TB001; once-daily subcutaneous injection, on Days 1-7 in MAD stage
Placebo Comparator: Single-dose of placebo; In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1.	Drug: Placebo; once-daily subcutaneous injection, on Day 1 in SAD stage; Drug: Placebo; once-daily subcutaneous injection, on Days 1-7 in MAD stage
Placebo Comparator: Multiple-dose of placebo; In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days.	Drug: Placebo; once-daily subcutaneous injection, on Day 1 in SAD stage; Drug: Placebo; once-daily subcutaneous injection, on Days 1-7 in MAD stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shenzhen Turier Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TB001CT0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No