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.
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
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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
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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…
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