Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & Peopl… (NCT05802264) | Clinical Trial Compass
RecruitingPhase 1
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
Australia, New Zealand108 participantsStarted 2023-03-21
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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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 between 18 and 32 kg/m2
* Subject has an FEV1 of \>90% of predicted normal value
* Subject has normal or clinically acceptable physical examination, vital signs, clinical laboratory values, and ECG at Screening.
* Female subjects must be of non-childbearing potential or male/female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures
Part C: Each subject must meet the following criteria to be enrolled in Part C of this study.
* Subject has signed, dated, and received a copy of the IRB/IEC-approved written ICF.
* Age 16 years or older
* Confirmed diagnosis of CF, including sweat chloride \>60 mM.
* Subject is either: Being treated with an approved CFTR modulator for at least 28 days prior to Screening, or Not being treated with a CFTR modulator
* FEV1:
* For subjects on CFTR modulators: FEV1 ≥40% and ≤90%
* For subjects not on CFTR modulators: FEV1 ≥40% and ≤100%
* Stable CF disease and treatment regiment
* Female subjects must be of non-childbearing potential or male/female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures
Exclusion Criteria:
Part A and Part B: Any subjec…
What they're measuring
1
Adverse Events (AEs), and Serious Adverse Events (SAEs)