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A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants

NCT03173573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2018-09-06

No results posted yet for this study

Summary

This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose escalation study in healthy male participants. Part 2 is a single dose, open-label study in healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants. Part 4 is a randomised, double-blind, placebo-controlled, dose-escalation study in healthy male and female participants.Part 5 is a single dose, open-label study in male and female participants with CF.

Conditions

Interventions

DRUG

FDL176

CFTR modulator

DRUG

Placebo

Placebo for FDL176

Sponsors & Collaborators

  • Flatley Discovery Lab LLC

    lead OTHER

Principal Investigators

  • Claudia Ordonez, MD · Flatley Discovery Lab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03173573 on ClinicalTrials.gov