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

NCT05308940 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-04-13

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Shenzhen Turier Biotech Co., Ltd

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2022-08-23
Completion
2022-08-23

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308940 on ClinicalTrials.gov