Actively Recruiting
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
Led by Cystetic Medicines, Inc. · Updated on 2025-02-12
108
Participants Needed
5
Research Sites
140 weeks
Total Duration
On this page
Sponsors
C
Cystetic Medicines, Inc.
Lead Sponsor
D
DevPro Biopharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has signed, dated, and received a copy of the IRB/IEC-approved written informed consent form
- For Parts A and B: Male or female aged 18 to 55 years
- For Parts A and B: Body mass index between 18 and 32 kg/m2
- For Parts A and B: Forced expiratory volume in 1 second (FEV1) greater than 90% of predicted normal
- For Parts A and B: Normal or clinically acceptable physical exam, vital signs, lab values, and ECG at screening
- Female subjects of childbearing potential and male subjects agree to use highly effective contraception
- For Part C: Age 16 years or older
- For Part C: Confirmed cystic fibrosis diagnosis with sweat chloride over 60 mM
- For Part C: Either treated with an approved CFTR modulator for at least 28 days prior to screening or not treated with a CFTR modulator
- For Part C: FEV1 between 40% and 90% for subjects on CFTR modulators
- For Part C: FEV1 between 40% and 100% for subjects not on CFTR modulators
- For Part C: Stable cystic fibrosis disease and treatment regimen
- Female subjects of childbearing potential and male subjects agree to use highly effective contraception
You will not qualify if you...
- History or evidence of any clinically significant pulmonary condition (Parts A and B)
- History or evidence of any clinically significant diseases or conditions (Parts A and B)
- History of any type of malignancy (Parts A and B)
- Active COVID-19 infection within 4 weeks prior to screening (Parts A, B, and C)
- Positive for HIV antibodies, hepatitis B surface antigen, hepatitis C antibodies, or positive tuberculosis test at screening (Parts A and B)
- Self-reported lower respiratory tract infection within 6 weeks (Parts A and B)
- Evidence of any active or suspected infections within 4 weeks (Parts A and B)
- Active or former smoker (Parts A and B)
- History of alcohol or drug abuse in the past year (Parts A and B)
- Positive drug, nicotine, or alcohol tests or alcohol consumption within 24 hours prior to dosing (Parts A and B)
- Participation in another clinical study or treatment with investigational drugs within 28 days or 5 half-lives (Parts A, B, and C)
- Female subjects who are pregnant or breastfeeding (Parts A, B, and C)
- Any episode of paradoxical bronchospasm in past 12 months (Parts A and B)
- Pacemaker, abnormal heart rhythm, prolonged QT interval, or bundle branch block (Parts A and B)
- Pulse below 40 or above 100 bpm, systolic blood pressure over 140 mmHg, or diastolic blood pressure over 90 mmHg at screening (Parts A and B)
- Type I or II diabetes requiring medication (Parts A and B)
- Vaccination within 30 days prior to dosing (Parts A and B)
- Use of certain immunosuppressant therapies within 6 months prior to screening (Parts A and B)
- Use of antibody or therapeutic biologic products within 6 months prior to screening (Parts A and B)
- Use of oral, intravenous, or intramuscular steroids within 4 weeks prior to screening (Parts A and B)
- Not vaccinated with COVID-19 vaccine per local guidelines within 30 days prior to dosing (Parts A and B)
- History of illness or condition that might affect study results or pose risk (Part C)
- Abnormal lab tests including hemoglobin, bilirubin, liver enzymes, or creatinine clearance (Part C)
- Recent acute respiratory infection or treatment change within 28 days before screening (Part C)
- Acute illness not related to cystic fibrosis within 14 days before first dose (Part C)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
Actively Recruiting
2
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
3
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032
Actively Recruiting
4
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
5
New Zealand Clinical Research
Christchurch, New Zealand
Actively Recruiting
Research Team
M
Martin Burke, MD, PhD
CONTACT
D
Daniele Tompkins, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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