Evaluate Pharmacokinetic/Pharmacodynamic and Safety/Tolerability of AYP-101 in Healthy Subjects

Phase 1 Completed 26 enrolled AMIpharm Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. injection in Healthy Subjects A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose

Timeline

Start: 2022-08-10
Primary completion: 2023-08-16
Completion: 2023-08-23

Publications

Lee HJ, Jiang X, Abd El-Aty AM, Jeong JH, Chung JY. Phase 1 study of AYP-101 (soybean phosphatidylcholine): safety, pharmacokinetics, and lipid profile effects for reducing submental fat. Lipids Health Dis. 2024 Dec 28;23(1):426. doi: 10.1186/s12944-024-02387-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Polyene Phosphatidylcholine	Small molecule	250 mg	Subcutaneous
Subject	Polyene Phosphatidylcholine	Small molecule	500 mg	Subcutaneous

Indications

No indication recorded.