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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-08-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

TB001

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

TB001

Intervention Type DRUG

once-daily subcutaneous injection, on Days 1-7 in MAD stage

Single-dose of placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Multiple-dose of placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once-daily subcutaneous injection, on Days 1-7 in MAD stage

Interventions

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TB001

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

Intervention Type DRUG

TB001

once-daily subcutaneous injection, on Days 1-7 in MAD stage

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Placebo

once-daily subcutaneous injection, on Days 1-7 in MAD stage

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes