drugset / Trial / NCT06756490
A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
Phase 1
Recruiting
30 enrolled
Sichuan Huiyu Pharmaceutical Co., Ltd
First Affiliated Hospital Xi'an Jiaotong University · collabPeking Union Medical College Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study is to evaluate the safety of HY-2003 in subjects with moderate to severe submental fat accumulation at different doses and dosing frequencies in comparison with the positive control and placebo. The secondary objectives include: Evaluating the pharmacokinetic characteristics of HY-2003 after a single administration in humans and obtaining preliminary pharmacokinetic parameters; Evaluating the efficacy of HY-2003 under different doses and dosing frequencies, compared with the positive control and placebo, in the treatment of subjects with moderate to severe submental fat accumulation.
Timeline
- Start
- 2024-12-26
- Primary completion
- 2026-12-06
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BELKYRA | Unknown | — | — |
| Subject | Deoxycholic Acid | Small molecule | 5 mg/ml | Subcutaneous |
| Subject | Deoxycholic Acid | Small molecule | 10 mg/ml | Subcutaneous |
Indications
No indication recorded.