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A Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401

NCT05195541 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-10

No results posted yet for this study

Summary

This study is a Phase Ib/II clinical study. Phase 1b was a single-center, nonrandomized, single-arm study to evaluate the safety, PK profile, preliminary efficacy, and immunogenicity of different groups (SC) of CU-20401 in the submental fat accumulation population. Phase 2 is a multicenter, randomized, placebo parallel-controlled study to evaluate the safety, efficacy, and immunogenicity of the preferred group (SC) of CU-20401 in a submental fat accumulation population.

Conditions

  • Safety

Interventions

DRUG

CU-20401

Subcutaneous injection in the subcutaneous fat area，0.2ml

Sponsors & Collaborators

  • Cutia Therapeutics（Wuxi）Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • byron zhu', MD · CMO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-02-27
Primary Completion
2022-12-30
Completion
2022-12-30

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 NCT05195541 on ClinicalTrials.gov