Cystic FibrosisPhase 1ABCINCT05802264
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
A Phase 1 study testing ABCI in people with Cystic Fibrosis, run by Cystetic Medicines, Inc. at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- ABCI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 21 Mar 2023to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Part A and Part B: Any subject who meets any of these criteria must be excluded from Part A and Part B of this study:
- Subject has history or evidence of any clinically significant pulmonary condition
- Subject has history or evidence of any clinically significant diseases or conditions
- Subject has history of malignancy of any type
- Subject has an active COVID-19 infection within 4 weeks
- Subject is positive for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies, or has a positive QuantiFERON®-tuberculosis Gold (QFT-G) test for tuberculosis at Screening
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- Subject has a self-reported lower respiratory tract infection within 6 weeks
- Subject has evidence of any active or suspected bacterial, viral, fungal or parasitic infections within the past 4 weeks
- A subject who is an active smoker or a former smoker
- Subject has history of alcohol or drug abuse in the past year
- Subject has tested positive for drugs (including cannabis), nicotine/cotinine, and/or alcohol use at Screening, subject has consumed alcohol within 24 hours prior to Visit 3
- Subject has participated in any clinical study or had been treated with any investigational drugs within 28 days or 5 half-lives
- Female subject who is pregnant or breastfeeding.
- Subject has any episode of paradoxical bronchospasm in the past 12 months.
- Subject has pacemaker; is not in sinus rhythm; has a corrected QT interval (QTc; using Fridericia's [QTcF] formula) of >450 ms (for males) and >470 ms (for females); or has a left bundle branch block or bifascicular block.
- Subject has a pulse <40 or >100 bpm; systolic blood pressure >140 mmHg, or diastolic blood pressure >90 mmHg at Screening
- Subject has Type I or II diabetes requiring medication.
- Subject has received any vaccine within 30 days prior to Day 1.
- Subject has received any of the following immunosuppressant therapies within 6 months prior to Screening: imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, or methotrexate.
- Subject has received any antibody or therapeutic biologic product during the 6 months prior to Screening.
- Subject has received any oral, intravenous, or intramuscular steroid within 4 weeks prior to Screening. Intrathecal or intraarticular steroids are permitted.
- A subject who is not vaccinated with the COVID-19 vaccine with appropriate window from last dose of vaccine to Screening per local guidelines, policies, and availability within 30 days prior to Day 1.
- Part C: Any subject who meets any of these criteria must be excluded from Part C of this study:
- History of any illness or any clinical condition that might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
- Any of the following abnormal laboratory tests: Hemoglobin, Total bilirubin, liver enzymes or creatine clearance
- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for sinopulmonary disease within 28 days before the screening visit.
- An acute illness not related to CF within 14 days before the first dose of study drug.
- Subject has an active COVID-19 infection within 4 weeks prior to screening.
- Ongoing or prior participation in a study of an investigational treatment within 28 days or 5 terminal half-lives (whichever is longer) before screening.
- Female subject who is pregnant or breastfeeding.
- Please refer to study protocol for the complete inclusion/exclusion criteria list.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Australia4 sites, 4 recruiting
- Recruiting
The Prince Charles Hospital
Brisbane, Queensland, 4032
Ieuan Evans, MD
Michelle Wood
- Recruiting
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Yashneel Prasad, MD
Joelle Bourke
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Christopher Daley, MD
Corinne Van Asha
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Jimmy Chien, MD
Tracey Burns
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research
Christchurch
Cory Sellwood, MD
David Lee
About this study
Official title: 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)
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
- Being tested
- ABCI, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCICombination product
Also called Amphotericin B Cystetic for Inhalation
Subjects will receive ABCI via oral inhalation
PlaceboCombination product
Subjects will receive ABCI via oral inhalation
| Study group | Role | What they receive |
|---|---|---|
| Part A Healthy Volunteer | Experimental | Subjects will be assigned to one of six planned dose cohorts and receive single doses of ABCI (0.5mg, 1.0mg, 2.0mg, 4.0mg, 6.0mg, 10.0mg). In each cohort, six subjects will receive ABCI and 2 will receive placebo Receives: Combination Product: ABCI; Combination Product: Placebo |
| Part B Healthy Volunteer | Experimental | Subjects will be assigned to one of three planned dose cohorts and receive a loading dose and multiple ascending doses of ABCI (loading dose 1.5mg/0.5mg daily, loading dose 6.0mg/2.0 daily, loading dose 10.0mg/4.0mg daily). In each cohort, six subjects will receive ABCI and 2 will receive placebo. Receives: Combination Product: ABCI; Combination Product: Placebo |
| Part C People with Cystic Fibrosis | Experimental | Subjects will be assigned to one of two planned dose cohorts of ABCI (loading dose 1.5 mg/0.5 mg daily, loading dose 6.0mg/2.0mg daily, loading dose 10.0mg/4.0mg daily) for a total of 28 days of open-label study drug administration. Up to 36subjects with CF, including 2 sentinels subjects not on cystic fibrosis transmembrane conductance regulator (CFTR) modulators will be enrolled. The 2 sentinel subjects will receive the medium dose/regimen. If the medium dose/regimen is tolerated, the remaining subjects with CF may receive the low, medium, high dose/regimen of ABCI and may be either on CFTR modulators or not on CFTR modulators. It is anticipated that approximately 24 subjects will be enrolled as follows: 8 high, 8 medium, and 8 low dose/regimen. Receives: Combination Product: ABCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs), and Serious Adverse Events (SAEs)
The safety and tolerability of ABCI following oral inhalation of single and multiple ascending doses in healthy subjects (Parts A and B), and in people with Cystic Fibrosis (Part C) will be assessed
Measured: up to 10 weeks
Secondary outcomes (12)
Pharmacokinetics (PK) Profile - SAD Cmax
Pharmacokinetics Characteristics in Single Ascending Dose HV Subjects: Observed maximum concentration (Cmax)
Measured: 1 day
Pharmacokinetics (PK) Profile - SAD Tmax
Pharmacokinetics Characteristics in Single Ascending Dose HV Subjects: time to reach maximum concentration (Tmax)
Measured: 1 day
Pharmacokinetics (PK) Profile - SAD AUC0-24
Pharmacokinetics Characteristics in Single Ascending Dose HV Subjects: Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24)
Measured: 1 day
Pharmacokinetics (PK) Profile - SAD AUClast
Pharmacokinetics Characteristics in Single Ascending Dose HV Subjects: Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Measured: 1 day
Pharmacokinetics (PK) Profile - SAD AUCinf
Pharmacokinetics Characteristics in Single Ascending Dose HV Subjects: Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)
Measured: 1 day
Pharmacokinetics (PK) Profile - SAD AUCtau
Pharmacokinetics Characteristics in Single Ascending Dose HV Subjects: Area under the concentration- concentration-time curve over the dosing interval (AUCtau)
Measured: Up to 28 days
Pharmacokinetics (PK) Profile - MAD Cmax
Pharmacokinetics Characteristics in Multiple Ascending Dose HV Subjects: Observed maximum concentration (Cmax)
Measured: Up to 28 days
Pharmacokinetics (PK) Profile - MAD Tmax
Pharmacokinetics Characteristics in Multiple Ascending Dose HV Subjects: time to reach maximum concentration (Tmax)
Measured: Up to 28 days
Pharmacokinetics (PK) Profile - MAD AUC0-24
Pharmacokinetics Characteristics in Multiple Ascending Dose HV Subjects: Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24)
Measured: Up to 28 days
Pharmacokinetics (PK) Profile - MAD Plasma AmB assessments
Pharmacokinetics Characteristics in Multiple Ascending Dose HV Subjects: Plasma AmB assessments
Measured: Up to 84 days
Pharmacokinetics (PK) Profile - MAD AmB concentrations in BAL fluid
Pharmacokinetics Characteristics in Multiple Ascending Dose HV Subjects: AmB concentrations in BAL fluid after study drug administration
Measured: Up to 29 days
AmB concentrations - Subjects with CF
Cumulative effect on pre-dose AmB concentrations through Day 29 and assessment of washout through Day 42
Measured: Through 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start21 Mar 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cystetic Medicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DevPro Biopharma
- Responsible party
- Sponsor
- Investigators
- Martin Burke, MD, PhD, Study chair, Founder of cystetic Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802264
- Sponsor's protocol ID
- CM001001
- Acronym
- ABCI
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05802264
- Acronym / sponsor ID
- ABCI / CM001001
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Cystetic Medicines, Inc.Industry (pharma, biotech, devices)
- Collaborators
- DevPro Biopharma
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A Healthy Volunteer | Experimental | Combination Product: ABCI, Combination Product: PlaceboSubjects will be assigned to one of six planned dose cohorts and receive single doses of ABCI (0.5mg, 1.0mg, 2.0mg, 4.0mg, 6.0mg, 10.0mg). In each cohort, six subjects will receive ABCI and 2 will receive placebo |
| Part B Healthy Volunteer | Experimental | Combination Product: ABCI, Combination Product: PlaceboSubjects will be assigned to one of three planned dose cohorts and receive a loading dose and multiple ascending doses of ABCI (loading dose 1.5mg/0.5mg daily, loading dose 6.0mg/2.0 daily, loading dose 10.0mg/4.0mg daily). In each cohort, six subjects will receive ABCI and 2 will receive placebo. |
| Part C People with Cystic Fibrosis | Experimental | Combination Product: ABCISubjects will be assigned to one of two planned dose cohorts of ABCI (loading dose 1.5 mg/0.5 mg daily, loading dose 6.0mg/2.0mg daily, loading dose 10.0mg/4.0mg daily) for a total of 28 days of open-label study drug administration. Up to 36subjects with CF, including 2 sentinels subjects not on cystic fibrosis transmembrane conductance regulator (CFTR) modulators will be enrolled. The 2 sentinel subjects will receive the medium dose/regimen. If the medium dose/regimen is tolerated, the remaining subjects with CF may receive the low, medium, high dose/regimen of ABCI and may be either on CFTR modulators or not on CFTR modulators. It is anticipated that approximately 24 subjects will be enrolled as follows: 8 high, 8 medium, and 8 low dose/regimen. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (31 listed)
- Part A and Part B: Any subject who meets any of these criteria must be excluded from Part A and Part B of this study:
- Subject has history or evidence of any clinically significant pulmonary condition
- Subject has history or evidence of any clinically significant diseases or conditions
- Subject has history of malignancy of any type
- Subject has an active COVID-19 infection within 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABCIAlso: Amphotericin B Cystetic for InhalationSubjects will receive ABCI via oral inhalation | Combination product | Part A Healthy Volunteer, Part B Healthy Volunteer, Part C People with Cystic Fibrosis |
| PlaceboSubjects will receive ABCI via oral inhalation | Combination product | Part A Healthy Volunteer, Part B Healthy Volunteer |
Primary outcome
Adverse Events (AEs), and Serious Adverse Events (SAEs)
Time frame: up to 10 weeks
The safety and tolerability of ABCI following oral inhalation of single and multiple ascending doses in healthy subjects (Parts A and B), and in people with Cystic Fibrosis (Part C) will be assessed
12 secondary outcomes
Pharmacokinetics (PK) Profile - SAD Cmax
Time frame: 1 day
Pharmacokinetics (PK) Profile - SAD Tmax
Time frame: 1 day
Pharmacokinetics (PK) Profile - SAD AUC0-24
Time frame: 1 day
Pharmacokinetics (PK) Profile - SAD AUClast
Time frame: 1 day
Pharmacokinetics (PK) Profile - SAD AUCinf
Time frame: 1 day
Pharmacokinetics (PK) Profile - SAD AUCtau
Time frame: Up to 28 days
Pharmacokinetics (PK) Profile - MAD Cmax
Time frame: Up to 28 days
Pharmacokinetics (PK) Profile - MAD Tmax
Time frame: Up to 28 days
Pharmacokinetics (PK) Profile - MAD AUC0-24
Time frame: Up to 28 days
Pharmacokinetics (PK) Profile - MAD Plasma AmB assessments
Time frame: Up to 84 days
Pharmacokinetics (PK) Profile - MAD AmB concentrations in BAL fluid
Time frame: Up to 29 days
AmB concentrations - Subjects with CF
Time frame: Through 42 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Burke, MD, PhD study chair
Founder of cystetic Medicines
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABCI in people with Cystic Fibrosis, run by Cystetic Medicines, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Burke, MD, PhD (217-244-8726, mburke@cysteticmedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs), and Serious Adverse Events (SAEs) (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.