A Single and Multiple Dose Study to Evaluate the Safety and Effects of Inhaled ICF001 Dry Powder in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ICF001; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Q-Pharm Pty Ltd
      • Contact: Michael Wong, Dr, MD, MPhil, BMedSci; Phone Number: 0737072720; Email: m.wong@nucleusnetwork.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1- SAD: ICF001; Participants will receive a single inhaled dose of ICF001 or placebo at 5 escalating dose levels from Day 1 to 3, under fasting conditions.	Drug: ICF001; ICF001 capsule-based inhalation powders.; Drug: Placebo; Matching-placebo capsule-based inhalation powders.
Experimental: Part 2- MAD: ICF001; Participants will receive a multiple inhaled doses of ICF001 or placebo at 4 escalating dose levels from Days 1 to 7, under fasting conditions.	Drug: ICF001; ICF001 capsule-based inhalation powders.; Drug: Placebo; Matching-placebo capsule-based inhalation powders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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		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		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.	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		From start of the study up to follow up (up to 38 days [SAD] and 50 Days [MAD])

Secondary Outcome Measures

Outcome Measure	Time Frame
SAD and MAD: Maximum Observed Plasma Concentration (Cmax) of ICF001 and its Active Metabolite (IC001-R1)	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)	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)	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)	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)	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)	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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	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)	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)	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	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)	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)	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

Collaborators and Investigators

• Sponsor: VIVID CLINICAL SERVICES PTY LTD
• Investigators: Study Director: Jian Wang, VIVID CLINICAL SERVICES PTY LTD

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): August 26, 2027

Study Registration Dates

• First Submitted: August 31, 2026
• First Submitted That Met QC Criteria: August 31, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: nIC001-202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No