Safety and Tolerability of CFTX-1554 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: CFTX-1554

• Registration Number: NCT05260658
• Lead Sponsor: Confo Therapeutics

Brief Summary

The study will consist of 2 parts, i.e. a single ascending dose part with integrated food effect assessment and assessment of relative bioavailability (Part A), and a multiple ascending dose part (Part B).

Part A will have a randomized, double-blind, placebo-controlled design. Subjects will receive single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition) in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under fasted conditions (Period 1) (1 single dose level only) will be assessed.

Part B will have a randomized, double-blind, placebo-controlled design, assessing multiple ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-09
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A placebo	Placebo	Single placebo administration in study Part A
Part B: CFTX-1554 Multiple Ascending Dose (MAD)	CFTX-1554	Up to 4 dose levels with CFTX-1554 in Part B. Doses and dosing frequency will be decided based on the results of study Part A.
Part B placebo	Placebo	Multiple placebo administration in study Part B
Part A: CFTX-1554 Single Ascending Dose (SAD)	CFTX-1554	Up to 7 dose levels with CFTX-1554 administered as oral liquid formulation under fasted conditions (at 1 single dose level only, drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions, will be assessed)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Day -1 through Day 13 (Single Ascending Dose study part) or Day 26 (Multiple Ascending Dose study part)	Number of Participants With Adverse Events Following Oral Administration of CFTX-1554 in SAD (Part A) and MAD (Part B)

Trial Locations

Locations (1)

PRA Health Sciences; 🇳🇱 Groningen, Netherlands