NCT05607589

The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult Subjects

A Phase 1, First-in-human, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 After SAD and MAD in Healthy Adult Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, First-in-human, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 after Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects

Detailed description

DWP213388 will be administered to the study subjects, according to a randomized, double-blind, and placebo-controlled design. The administration will be a single or multiple oral doses for healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWP213388	immunosuppressant
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-02-20
• Completion: 2024-03-08
• First posted: 2022-11-07
• Last updated: 2024-11-05

Regulatory

• FDA-regulated drug study