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

NCT05802264 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-02-12

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

ABCI

Subjects will receive ABCI via oral inhalation

COMBINATION_PRODUCT

Placebo

Subjects will receive ABCI via oral inhalation

Sponsors & Collaborators

  • DevPro Biopharma

    collaborator INDUSTRY

  • Cystetic Medicines, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Burke, MD, PhD · Founder of cystetic Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

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 NCT05802264 on ClinicalTrials.gov