NCT05716919

Multiple Ascending Dose Study of CG200745 'Ivaltinostat' Oral Capsule

A Phase I, Double Blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'Ivaltinostat' Capsule in Healthy Male Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Machaon Biotherapeutics, Inc. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male Volunteers

Conditions

• Hematologic Malignancy
• Solid Tumor
• Fibrosis

Interventions

Type	Name	Description
DRUG	Ivaltinostat	Ivaltinostat capsule
OTHER	Placebo	Placebo capsule

Timeline

• Start date: 2023-03-09
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-02-08
• Last updated: 2023-10-23

Locations

1 site across 1 country: South Korea