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

NCT07804628 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: nIC001-202601
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (24)

• 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

Study Arms (2)

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.

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.

Drug: ICF001; Drug: Placebo

Interventions

ICF001 DRUG

ICF001 capsule-based inhalation powders.

Part 1- SAD: ICF001; Part 2- MAD: ICF001

Placebo DRUG

Matching-placebo capsule-based inhalation powders.

Part 1- SAD: ICF001; Part 2- MAD: ICF001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VIVID CLINICAL SERVICES PTY LTD: lead

Study Sites (1)

Q-Pharm Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

Study Officials

• Jian Wang

  VIVID CLINICAL SERVICES PTY LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): August 26, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)