Healthy VolunteersPhase 1NCT07804628
A Single and Multiple Dose Study to Evaluate the Safety and Effects of Inhaled ICF001 Dry Powder in Healthy Participants
A Phase 1 study testing ICF001 in people with Healthy Volunteers, run by VIVID CLINICAL SERVICES PTY LTD at 1 site in Australia.
Trial summary
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristics of ICF001 following inhaled administration of single and multiple ascending doses in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ICF001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2026to 26 Aug 2027
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the study procedures and methods, voluntarily participate in this study, and provide written informed consent.
- Healthy adult participants aged 18 to 55 years (inclusive), both genders.
- Body Mass Index (BMI) equal to (=) weight/height squared kilogram per meter square (kg/m^2)): 18 less than or equal to (<=) BMI <=32; male weight greater than or equal to (>=) 50.0 kilogram (kg) and less than (<) 100.0 kg, female weight >=45.0 kg and <100.0 kg.
- Confirmed to have no clinically significant abnormalities through physical examination, laboratory tests, vital signs assessment, and electrocardiogram (ECG), and determined by the investigator to be medically healthy.
- Participants whose peak inspiratory flow rate measured by In-Check^TM DIAL G16 is between 30 to 60 liters per minute (L/min) and whose total inspiratory duration exceeds 2 seconds.
- Participants must be able to correctly and effectively use the inhaler device during the screening period and throughout the study.
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- Sexually active female participants of childbearing potential must agree to use effective contraception from screening until 35 days after the last dose and must not become pregnant or donate eggs during this period; Sexually active male participants with partners of childbearing potential must agree to use effective contraception from the first dose until 95 days after the last dose and must not donate sperm during this time; their fertile male or female partners must also agree to use effective contraception during this period.
- Ability to successfully complete test dosing procedure following inhalation training on Day-1.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
Who cannot join
- Participants with a history of any clinically significant disease (including both past and current medical conditions), including but not limited to respiratory, cardiovascular, neurological, gastrointestinal, hematologic, endocrine, immune, dermatologic, malignancy, neuropsychiatric, ophthalmologic, or metabolic disorders, or any other condition that, in the opinion of the investigator (or designee), would make the participant unsuitable for participation in the study. A history of bariatric surgery or prior cholecystectomy; a history of eczema (provided no use of topical or systemic steroid treatments within 3 months prior to screening); a history of gestational diabetes that has fully resolved; current or past attention deficit hyperactivity disorder (ADHD), anxiety, or depression (provided no use of antidepressant medication within 6 months prior to screening); and Gilbert's syndrome are not considered exclusionary, provided they are not currently clinically significant and are acceptable at the investigator's discretion.
- Participants who have undergone any major surgery within 3 months, or any minor surgery within 1 months prior to dosing, or who plan to undergo surgery during the study, or who have undergone surgery that may significantly affect the pharmacokinetic (PK) or safety evaluation of the study drug.
- Participants with clinically significant oral diseases that, in the investigator's judgment, may affect the study (e.g., oral candidiasis, oral ulcers, lesions of the oral mucosa, etc.).
- Participants with clinically significant nasal diseases such as severe rhinitis, sinusitis, nose cavity and nose septum infections and lesions.
- Risk of bleeding: History of bleeding disorders, active peptic ulcer, or history of gastrointestinal bleeding; abnormal platelet count, international normalized ratio (INR), or activated partial thromboplastin Time (APTT) during the screening period.
- History of asthma, chronic obstructive pulmonary disease (COPD), or reactive airway disease, or pulmonary function test findings consistent with asthma or COPD.
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- History of orthostatic hypotension, unexplained syncope, or hypertension.
- During screening or re-screening, participants with a systolic blood pressure of <90 millimeters of mercury (mmHg) or a diastolic blood pressure of <50 mmHg after sitting for 5 minutes.
- During screening or re-screening, participants with a systolic blood pressure of greater than (>) 140 mmHg or a diastolic blood pressure of >90 mmHg after sitting for 5 minutes.
- During screening or re-screening, participants with a heart rate of >100 beats/minute after sitting for 5 minutes.
- Participants with a fever (temperature >37.5 degrees Celsius [°C]) or symptomatic respiratory infection within 1 month prior to dosing, or those with any infection requiring systemic antibiotics/antiviral medications within 3 months prior to screening, or those with a history of recurrent infections.
- Positive for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, and hepatitis C.
- During screening/baseline visit, participants with alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), or total bilirubin >=1.5 the upper limit of normal (ULN).
- Screening/Baseline Visit: Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) <80 percentage (%) of predicted value, or FEV1/FVC < 0.7, or an oxygen saturation (SpO₂) <95%. Spirometry may be repeated at the same visit for a total of 3 tests if initial results are considered unacceptable due to poor effort or technical issues, with the best value recorded.
- Participants who smoked (including vaping) within 3 months prior to dosing, or with positive cotinine test results.
- Participants with potential risk of airway hyperreactivity, such as those with prolonged exposure to dust or harmful gases.
- Participants with a history of heavy alcohol consumption within 3 months prior to screening, defined as >14 alcohol units per week for males and >10 alcohol units per week for females (where 1 standard unit =375 milliliter (mL) of mid-strength beer (3.5% alcohol/volume), 100 mL of wine (13.5% alcohol/volume), or 30 mL of spirits (40% alcohol/volume)), or with a positive breath alcohol test, or who are unable to abstain from alcohol during the study period.
- Participants who have received any known moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (for example; barbiturates, phenothiazines, cimetidine, carbamazepine) within the 30 days prior to the study, and for whom the investigator believes that these medications may affect the participant's safety or the validity of the study results.
- Participants with a history of drug abuse within 3 months prior to screening, or those with a positive urine drug screen.
- Participants who have participated in any clinical trials of drugs or medical devices within 5 half-lives or 3 months after the last dose/administration, whichever is longer, prior to screening.
- Participants who have donated or lost >=400 mL of blood within 30 days prior to dosing.
- Participants with difficulty in intravenous blood collection or intolerance to venipuncture, or those with a history of vasovagal syncope.
- Participants who have used any medication (including prescription drugs, over-the-counter drugs, vitamin supplements, or traditional medicines, especially anticoagulants, antiplatelet agents, non-steroidal anti-inflammatory drugs, vasodilators, or potent CYP2C8 inhibitors such as gemfibrozil and rifampin) or received any health supplements or vaccines within 7 days prior to dosing (or 5 half-lives of the drug, whichever is longer).
- Participants who have consumed foods that may affect drug metabolism within 7 days prior to dosing (including grapefruit or grapefruit products, pitaya, mango, pomelo, etc.), or those with other dietary habits that the investigator believes may affect the absorption, distribution, metabolism, or excretion of the drug, or those who are unwilling to discontinue consuming the aforementioned foods during the study period.
- Participants who have consumed any coffee or tea, as well as beverages and foods containing coffee or tea ingredients, within 48 hours prior to dosing, or those who are unwilling to discontinue consuming these foods during confinement, and within 24 hours before each follow-up visit.
- Participants with special dietary requirements who cannot comply with a standard diet.
- Participants with a known allergy to the study drug or any of its components.
- Female participants who are pregnant or breastfeeding, or who have plans to become pregnant during the study period or within 2 months after the last dose.
- Participants are deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Q-Pharm Pty Ltd
Brisbane, Queensland, 4006
Michael Wong, Dr, MD, MPhil, BMedSci, 0737072720, m.wong@nucleusnetwork.com.au
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Single and Multiple Inhaled Doses of ICF001 Dry Powder in Healthy Adult Participants
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristics of ICF001 following inhaled administration of single and multiple ascending doses in healthy participants.
Read the detailed description
This study will consist of 2 parts: a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- ICF001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICF001Drug
ICF001 capsule-based inhalation powders.
PlaceboDrug
Matching-placebo capsule-based inhalation powders.
| Study group | Role | What they receive |
|---|---|---|
| Part 1- SAD: ICF001 | Experimental | Participants will receive a single inhaled dose of ICF001 or placebo at 5 escalating dose levels from Day 1 to 3, under fasting conditions. Receives: Drug: ICF001; Drug: Placebo |
| Part 2- MAD: ICF001 | Experimental | Participants will receive a multiple inhaled doses of ICF001 or placebo at 4 escalating dose levels from Days 1 to 7, under fasting conditions. Receives: Drug: ICF001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Local Tolerability Findings
Local tolerability includes observation of cough, wheezing, chest tightness, sore throat, choking cough, throat itching, and foreign object sensation in the throat.
Measured: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Findings
Laboratory parameters included hematology, blood chemistry, urinalysis, coagulation tests.
Measured: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Measured: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Pulmonary Function Test Abnormalities
Measured: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Vital signs included blood pressure, heart rate, respiratory rate, and body temperature.
Measured: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings
Measured: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Secondary outcomes (24)
SAD and MAD: Maximum Observed Plasma Concentration (Cmax) of ICF001 and its Active Metabolite (IC001-R1)
Measured: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Time of the Maximum Measured Plasma Concentration (Tmax) of ICF001 and its Active Metabolite (IC001-R1)
Measured: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Area Under the Plasma Concentration-Time Curve from Zero to the Last Measurable Time Point (AUC0-t) of ICF001 and its Active Metabolite (IC001-R1)
Measured: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Area Under the Plasma Concentration-Time Curve from Zero to Infinity (AUC0-∞) of ICF001 and its Active Metabolite (IC001-R1)
Measured: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Terminal Elimination Half-life (t½) of ICF001 and its Active Metabolite (IC001-R1)
Measured: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Terminal Elimination Rate Constant (λz) of ICF001 and its Active Metabolite (IC001-R1)
Measured: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD: Apparent Clearance (CL/F) of ICF001 Only
Measured: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
SAD: Apparent Volume of Distribution (Vd/F) of ICF001 Only
Measured: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
SAD: Mean Residence Time (MRT) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
SAD: Area Under the Curve Extrapolated Percentage (AUC_%Extrap) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
MAD: Area Under the Concentration-Time Curve from Zero to 12 Hours (AUC0-12) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Area Under the Plasma Concentration-Time Curve from Zero to the Last Measurable Time Point (AUC0-t) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Steady-state Average Concentration (Cavg,ss) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Maximum Plasma Concentration in Steady State (Cmax,ss) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Steady-state Trough Plasma Concentration (Ctrough,ss) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Time of the Maximum Measured Plasma Concentration Steady State (Tmax,ss) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUC0-τ, ss) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Apparent Clearance at Steady State (CLss/F) of ICF001 Only
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Apparent Volume of Distribution at Steady State (Vdss/F) of ICF001 Only
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Accumulation Ratio (Rac) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Degree of Fluctuation (DF) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
Steady-State Plasma Concentration Fluctuation (Swing) of ICF001 and its Active Metabolite IC001-R1
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Ratio of Maximum Plasma Concentration (RCmax) of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Ratio of Area Under the Plasma Concentration-Time Curve (RAUC) Following the last Dose of ICF001 and its Active Metabolite (IC001-R1)
Measured: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion14 May 2027 (estimated)
- Study completion26 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIVID CLINICAL SERVICES PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Wang, Study director, VIVID CLINICAL SERVICES PTY LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804628
- Sponsor's protocol ID
- nIC001-202601
- Status last verified
- Jul 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Single and Multiple Inhaled Doses of ICF001 Dry Powder in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07804628
- Acronym / sponsor ID
- nIC001-202601
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- VIVID CLINICAL SERVICES PTY LTDIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 4 Sep 2026 (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.
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristics of ICF001 following inhaled administration of single and multiple ascending doses in healthy participants.
Detailed description
This study will consist of 2 parts: a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1- SAD: ICF001 | Experimental | Drug: ICF001, Drug: PlaceboParticipants will receive a single inhaled dose of ICF001 or placebo at 5 escalating dose levels from Day 1 to 3, under fasting conditions. |
| Part 2- MAD: ICF001 | Experimental | Drug: ICF001, Drug: PlaceboParticipants will receive a multiple inhaled doses of ICF001 or placebo at 4 escalating dose levels from Days 1 to 7, under fasting conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Understand the study procedures and methods, voluntarily participate in this study, and provide written informed consent.
- Healthy adult participants aged 18 to 55 years (inclusive), both genders.
- Body Mass Index (BMI) equal to (=) weight/height squared kilogram per meter square (kg/m^2)): 18 less than or equal to (<=) BMI <=32; male weight greater than or equal to (>=) 50.0 kilogram (kg) and less than (<) 100.0 kg, female weight >=45.0 kg and <100.0 kg.
- Confirmed to have no clinically significant abnormalities through physical examination, laboratory tests, vital signs assessment, and electrocardiogram (ECG), and determined by the investigator to be medically healthy.
- Participants whose peak inspiratory flow rate measured by In-Check^TM DIAL G16 is between 30 to 60 liters per minute (L/min) and whose total inspiratory duration exceeds 2 seconds.
Key exclusion criteria (29 listed)
- Participants with a history of any clinically significant disease (including both past and current medical conditions), including but not limited to respiratory, cardiovascular, neurological, gastrointestinal, hematologic, endocrine, immune, dermatologic, malignancy, neuropsychiatric, ophthalmologic, or metabolic disorders, or any other condition that, in the opinion of the investigator (or designee), would make the participant unsuitable for participation in the study. A history of bariatric surgery or prior cholecystectomy; a history of eczema (provided no use of topical or systemic steroid treatments within 3 months prior to screening); a history of gestational diabetes that has fully resolved; current or past attention deficit hyperactivity disorder (ADHD), anxiety, or depression (provided no use of antidepressant medication within 6 months prior to screening); and Gilbert's syndrome are not considered exclusionary, provided they are not currently clinically significant and are acceptable at the investigator's discretion.
- Participants who have undergone any major surgery within 3 months, or any minor surgery within 1 months prior to dosing, or who plan to undergo surgery during the study, or who have undergone surgery that may significantly affect the pharmacokinetic (PK) or safety evaluation of the study drug.
- Participants with clinically significant oral diseases that, in the investigator's judgment, may affect the study (e.g., oral candidiasis, oral ulcers, lesions of the oral mucosa, etc.).
- Participants with clinically significant nasal diseases such as severe rhinitis, sinusitis, nose cavity and nose septum infections and lesions.
- Risk of bleeding: History of bleeding disorders, active peptic ulcer, or history of gastrointestinal bleeding; abnormal platelet count, international normalized ratio (INR), or activated partial thromboplastin Time (APTT) during the screening period.
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 |
|---|---|---|
| ICF001ICF001 capsule-based inhalation powders. | Drug | Part 1- SAD: ICF001, Part 2- MAD: ICF001 |
| PlaceboMatching-placebo capsule-based inhalation powders. | Drug | Part 1- SAD: ICF001, Part 2- MAD: ICF001 |
Primary outcome
Number of Participants With an Adverse Event (AE)
Time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants With Clinically Significant Change From Baseline in Local Tolerability Findings
Time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Local tolerability includes observation of cough, wheezing, chest tightness, sore throat, choking cough, throat itching, and foreign object sensation in the throat.
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Findings
Time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Laboratory parameters included hematology, blood chemistry, urinalysis, coagulation tests.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Pulmonary Function Test Abnormalities
Time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
Vital signs included blood pressure, heart rate, respiratory rate, and body temperature.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings
Time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])
24 secondary outcomes
SAD and MAD: Maximum Observed Plasma Concentration (Cmax) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Time of the Maximum Measured Plasma Concentration (Tmax) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Area Under the Plasma Concentration-Time Curve from Zero to the Last Measurable Time Point (AUC0-t) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Area Under the Plasma Concentration-Time Curve from Zero to Infinity (AUC0-∞) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Terminal Elimination Half-life (t½) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD and MAD: Terminal Elimination Rate Constant (λz) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: SAD: Predose, 5,15,30 mins,1,1.5,2,4,6,8,10,12,24,36,48 hrs postdose; MAD: Day 1: predose, 5,15,30 mins,1,1.5, 2,4,6,8,10,12 hrs post first dose; Days 2-7: predose; Day 7: 5,15,30 mins,1,1.5, 2,4,6,8,10,12,24 hours (Day 8) and 48 hours (Day 9) postdose
SAD: Apparent Clearance (CL/F) of ICF001 Only
Time frame: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
SAD: Apparent Volume of Distribution (Vd/F) of ICF001 Only
Time frame: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
SAD: Mean Residence Time (MRT) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
SAD: Area Under the Curve Extrapolated Percentage (AUC_%Extrap) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Predose, 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48 hours postdose
MAD: Area Under the Concentration-Time Curve from Zero to 12 Hours (AUC0-12) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Area Under the Plasma Concentration-Time Curve from Zero to the Last Measurable Time Point (AUC0-t) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Steady-state Average Concentration (Cavg,ss) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Maximum Plasma Concentration in Steady State (Cmax,ss) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Steady-state Trough Plasma Concentration (Ctrough,ss) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Time of the Maximum Measured Plasma Concentration Steady State (Tmax,ss) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUC0-τ, ss) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Apparent Clearance at Steady State (CLss/F) of ICF001 Only
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Apparent Volume of Distribution at Steady State (Vdss/F) of ICF001 Only
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Accumulation Ratio (Rac) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Degree of Fluctuation (DF) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
Steady-State Plasma Concentration Fluctuation (Swing) of ICF001 and its Active Metabolite IC001-R1
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Ratio of Maximum Plasma Concentration (RCmax) of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
MAD: Ratio of Area Under the Plasma Concentration-Time Curve (RAUC) Following the last Dose of ICF001 and its Active Metabolite (IC001-R1)
Time frame: Day 1: predose, 5, 15, 30 mins,1,1.5, 2, 4, 6, 8, 10,12 hrs post first dose; Days 2-7: predose; Day 7: 5, 15, 30 mins,1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours (Day 8) and 48 hours (Day 9) postdose
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 4 Sep 2026.
- 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.
Jian Wang study director
VIVID CLINICAL SERVICES PTY LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICF001 in people with Healthy Volunteers, run by VIVID CLINICAL SERVICES PTY LTD at 1 site in Australia.
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 9 inclusion and 29 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: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Adverse Event (AE) (time frame: From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])). The study lists 7 primary outcomes in all. 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 4 Sep 2026.