Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis

Recruiting Phase 1 Interventional Study
Cystic Fibrosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
16 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
108 (estimated)
Sponsor
Cystetic Medicines, Inc. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
This is a 3-part, single-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part A) and multiple-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part B), and a Phase 1b open-label study in subjects with CF (Part C) to assess the safety, tolerability, PK, and preliminary efficacy of ABCI. Subjects will …
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: Part A and Part B: Each subject must meet the following criteria to be enrolled in Part A and Part B of this study. * Subject has signed, dated, and received a copy of the IRB/IEC-approved written ICF. * Subject is male or female aged ≥18 to ≤55 years. * Subject has a BMI betwe…
Contacts

Martin Burke, MD, PhD

217-244-8726

mburke@cysteticmedicines.com

CONTACT

Daniele Tompkins, MA

973-983-3700

dtompkins@devprobiopharma.com

CONTACT