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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05308940

Enrollment

Registered

2022-04-04

Start date

2022-01-10

Completion date

2022-08-23

Last updated

2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGTB001

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026