Multiple Ascending Dose Study of CG200745 'Ivaltinostat' Oral Capsule

Phase 1

Active, not recruiting

• Conditions: Solid Tumor; Fibrosis; Hematologic Malignancy
• Interventions: Drug: Ivaltinostat; Other: Placebo

• Registration Number: NCT05716919
• Lead Sponsor: Machaon Biotherapeutics, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Study Start: 2023-03-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1 - 4	Ivaltinostat	Cohort 1 : 50 mg/day Cohort 2 : 100 mg/day Cohort 3: 200mg/day \[Cohort 4: 300mg/day: based on the result of Safety Review Meeting (SRM)\]
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetic measures (Cmax, Cmax-ss)	up to 4 weeks
Plasma Pharmacokinetic measures (AUC max, AUCmax-ss)	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events	Up to 4 weeks for each dosing cohort

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of