MedTrace Logo

Safety and Tolerability of CFTX-1554 in Healthy Subjects

NCT05260658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2023-09-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

CFTX-1554

CFTX-1554 is a new chemical entity that binds to the angiotensin II type 2 receptor (AT2R).

DRUG

Placebo

CFTX-1554 matching placebo

Sponsors & Collaborators

  • Confo Therapeutics

    lead INDUSTRY

Principal Investigators

  • Paolo Vicini, PhD · Confo Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2023-02-10
Completion
2023-02-10

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260658 on ClinicalTrials.gov