Actively Recruiting
A 3-part Study of ABCI: Randomized, Double-blind, Placebo-controlled Dose Studies in Healthy Volunteers and a 28-day Open-Label Study in People with Cystic Fibrosis
Led by Cystetic Medicines, Inc. · Updated on 2025-02-12
108
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cystetic Medicines, Inc.
Lead Sponsor
D
DevPro Biopharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Amphotericin B Cystetic for Inhalation (ABCI) in a three-part clinical trial to assess its safety, tolerability, how it is processed by the body, and early signs of effectiveness. The study includes healthy volunteers and people with cystic fibrosis (CF). It is a Phase 1 trial with parts that involve different dosing schedules and include both placebo-controlled and open-label designs, aiming to evaluate ABCI across various doses and participant groups. In Part A, healthy volunteers receive a single dose of ABCI or placebo across six dose levels. Part B involves healthy volunteers receiving a loading dose followed by multiple ascending doses over 14 or 28 days, again compared to placebo. Part C enrolls people with CF who receive ABCI in an open-label manner for 28 days at low, medium, or high doses, including some subjects not using CFTR modulators. In total, about 72 healthy volunteers and 36 people with CF will participate. Participants undergo screening within 30 days before starting treatment. Throughout the study, researchers monitor safety by tracking adverse events for up to 10 weeks and assess ABCI levels in the body through various pharmacokinetic measurements. The study also includes physical exams, vital signs, lab tests, and lung function tests. Participants may be asked to use contraception if applicable, and safety is closely observed with follow-up visits to ensure well-being.
CONDITIONS
Brief 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...
- Subjects must have signed and received a copy of the informed consent form.
- For Parts A and B: Male or female aged 18 to 55 years.
- BMI between 18 and 32 kg/m2 for Parts A and B.
- 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 for Parts A and B.
- Female subjects must be non-childbearing or agree to use highly effective contraception.
- For Part C: Age 16 years or older.
- Confirmed diagnosis of cystic fibrosis with sweat chloride over 60 mM.
- On an approved CFTR modulator for at least 28 days or not on a CFTR modulator for Part C.
- FEV1 between 40% and 90% for those on CFTR modulators; between 40% and 100% for those not on CFTR modulators.
- Stable cystic fibrosis disease and treatment regimen.
- Female subjects must be non-childbearing or agree to use highly effective contraception.
You will not qualify if you...
- History or evidence of significant pulmonary or other diseases for Parts A and B.
- History of any type of malignancy.
- Active COVID-19 infection within 4 weeks.
- Positive tests for HIV, hepatitis B or C, or tuberculosis.
- Recent lower respiratory tract infection or other infections within specified timeframes.
- Active or former smokers.
- History of alcohol or drug abuse within the past year.
- Positive drug, nicotine, or alcohol tests at screening.
- Participation in other clinical studies within 28 days or 5 half-lives.
- Pregnant or breastfeeding females.
- Episodes of paradoxical bronchospasm in the past 12 months.
- Certain heart conditions or abnormal ECG findings.
- Extreme vital sign measurements at screening.
- Diabetes requiring medication.
- Recent vaccination or certain immunosuppressant or steroid use.
- Not vaccinated according to local COVID-19 vaccine guidelines within 30 days prior.
- For Part C: Any illness or condition that risks or confounds study results.
- Abnormal lab tests including hemoglobin, bilirubin, liver enzymes, or creatinine clearance.
- Recent respiratory infections or therapy changes within specified timeframes.
- Active COVID-19 infection within 4 weeks before screening.
- Prior investigational treatment within 28 days or 5 terminal half-lives.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive ABCI or placebo via oral inhalation in dose cohorts. Healthy volunteers receive single or multiple ascending doses, and people with cystic fibrosis receive open-label study drug administration for 28 days.
Multiple visits during dosing period
Duration - Up to 10 weeks
Participants are monitored for adverse events and pharmacokinetic profiles following treatment.
Several follow-up visits for assessments
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
D
Daniele Tompkins, MA
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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