NCT05802264

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

A 3-part Study of ABCI: a Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Phase 1a Study in Healthy Volunteers (Part A), a Randomized, Double-blind, Placebo-controlled, 14- and 28-day Multiple-ascending Dose Phase 1a Study in Healthy Volunteers (Part B), and a 28-day Open-Label Phase 1b Study in Subjects with Cystic Fibrosis (Part C)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Cystetic Medicines, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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 be evaluated for eligibility during Screening within 30 days prior to Day 1 (Randomization; Visit 3). In Parts A and B, eligible healthy volunteers may be enrolled in the study and randomly allocated to treatment with ABCI or placebo as described below. In Part C, eligible subjects with CF may be enrolled in the study and receive treatment with ABCI as described below. Approximately 72 healthy subjects total will be randomized to 9 cohorts (48 subjects in 6 cohorts in Part A, 24 subjects in 3 cohorts in Part B) and approximately 36 subjects with CF will receive the low dose, medium dose (2 sentinel subjects), or high dose of ABCI in Part C.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ABCI	Subjects will receive ABCI via oral inhalation
COMBINATION_PRODUCT	Placebo	Subjects will receive ABCI via oral inhalation

Timeline

• Start date: 2023-03-21
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-04-06
• Last updated: 2025-02-12

Locations

5 sites across 2 countries: Australia, New Zealand