Trials / Completed
CompletedNCT05476094
Evaluate Pharmacokinetic/Pharmacodynamic and Safety/Tolerability of AYP-101 in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose Phase Ⅰ Study to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. Injection in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- AMIpharm Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 65 Years
- Healthy volunteers
- Accepted
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
Detailed description
This study is planed to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. injection in Healthy Subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Polyene Phosphatidylcholine | AYP-101 1 - 25 mg of essential phospholipids in 1 mL AYP-101 2 - 50 mg of essential phospholipids in 1 mL Placebo - Essential phospholipids in 1 mL 00 mg |
Timeline
- Start date
- 2022-08-10
- Primary completion
- 2023-08-16
- Completion
- 2023-08-23
- First posted
- 2022-07-27
- Last updated
- 2026-01-22
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05476094. Inclusion in this directory is not an endorsement.