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drugset / Trial / NCT05195541

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

NCT05195541 ↗

Phase 1/2 Completed 48 enrolled Cutia Therapeutics (Wuxi) Co., Ltd
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject CU-20401 Unknown 0.02 mg Subcutaneous
Subject CU-20401 Unknown 0.04 mg Subcutaneous
Subject CU-20401 Unknown 0.075 mg Subcutaneous
Subject CU-20401 Unknown 0.15 mg Subcutaneous

Indications

No indication recorded.