Safety, Tolerability, and Pharmacokinetics of DD-S052P in Healthy Volunteers
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study designed to evaluate the safety, tolerability, and pharmacokinetics of DD-S052P in healthy adult volunteers. The study consists of two parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. In the SAD part, participants will receive a single intravenous infusion of DD-S052P or placebo at increasing dose levels. In the MAD part, participants will receive multiple intravenous infusions of DD-S052P or placebo over several days. Safety and tolerability will be assessed through monitoring of adverse events, vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory tests. Pharmacokinetic assessments will be performed to characterize plasma concentrations of DD-S052P over time following single and multiple dosing. The results of this study will provide important information to support further clinical development of DD-S052P.
Timeline
- Start
- 2023-07-24
- Primary completion
- 2025-05-23
- Completion
- 2025-05-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DD-S052P | Unknown | — | Intravenous |
Indications
No indication recorded.