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

NCT05308940 | Completed Phase 1

• 1 other identifier: TB001CT0001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetics exposure of TB001 in SAD and MAD stage

  Day 1 , Day 7

• Observed immunogenicity of TB001 in MAD stage

  Day 1, Day 7, Day 14, Day 28

Study Arms (4)

Single-dose of TB001

EXPERIMENTAL

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

Multiple-dose of TB001

EXPERIMENTAL

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

Single-dose of placebo

PLACEBO COMPARATOR

In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1.

Drug: Placebo

Multiple-dose of placebo

PLACEBO COMPARATOR

In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days.

Drug: Placebo

Interventions

TB001 DRUG

once-daily subcutaneous injection, on Day 1 in SAD stage

Single-dose of TB001

Placebo DRUG

once-daily subcutaneous injection, on Day 1 in SAD stage

Single-dose of placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shenzhen Turier Biotech Co., Ltd: lead

Study Sites (1)

Shenzhen Turier Biotech Co., Ltd.

Shenzhen, Guangdong, 518122, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: January 10, 2022
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)