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A Phase 1 Clinical Study of CU-20401 in Chinese Healthy Population

NCT05173883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-10

No results posted yet for this study

Summary

This is an open-label, Part I/2/3/4 Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of a single subcutaneous injection of CU-20401 in healthy Chinese population, and to recommend an appropriate dose for subsequent clinical studies.

Conditions

  • Healthy Subjects

Interventions

DRUG

injection ，CU-20401

Subcutaneous injection，cohort A 6 sites

DRUG

injection ，placebo

Subcutaneous injection，just one site

Sponsors & Collaborators

  • Cutia Therapeutics（Wuxi）Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • TANIA LI, MM · CUTIA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-11-02
Completion
2023-11-02

Countries

  • China

Study Locations

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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 NCT05173883 on ClinicalTrials.gov