NCT05068466

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INCB054707

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB054707 When Administered Orally to Healthy Japanese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Incyte Biosciences Japan GK · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	INCB054707	Administered Orally
DRUG	Placebo	Administered Orally

Timeline

• Start date: 2021-10-21
• Primary completion: 2022-01-25
• Completion: 2022-01-25
• First posted: 2021-10-05
• Last updated: 2022-09-16

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study