The Safety and PK Study of Inhaled ICF004 in Healthy Chinese Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorRuijin Hospital
About this trial
The goal of this clinical trial is to learn about the safety of an inhaled study drug called ICF004 in healthy adults. ICF004 is being created to treat progressive lung scarring in the future. It will also learn how the body handles the drug over time.
The main questions it aims to answer are:
What medical problems or side effects do participants have when taking ICF004? How does the body absorb and metabolize ICF004? Researchers will compare ICF004 to a placebo (a look-alike powder that contains no active drug) to see if ICF004 is safe and well-tolerated.
Participants will:
Breathe in a single dose or multiple doses of ICF004 or a placebo using a dry powder inhaler; Stay at or visit the study clinic for checkups and tests; Give blood samples so researchers can measure the amount of drug in their blood.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Fully understand the study procedures and methods, volunteer to participate in this study, and sign the written informed consent form.
Healthy adult participants, male or female, aged 18 to 50 years (inclusive).
Body Mass Index (BMI) ≥ 18 and < 28 kg/m²; body weight ≥ 50.0 kg and < 90.0 kg for males, and ≥ 45.0 kg and < 90.0 kg for females.
Medically healthy as determined by the investigator, based on the absence of clinically significant abnormalities in physical examinations, laboratory tests, vital signs, chest X-ray, and electrocardiogram (ECG).
Disqualifiers
History of any clinically significant disease (including past and current history), including but not limited to respiratory, cardiovascular, gastrointestinal, hematological, endocrine, immunological, dermatological, malignant tumor, neuropsychiatric, ear/nose/throat (ENT), or metabolic diseases; or any other condition that, in the opinion of the investigator (or sub-investigator), makes the participant unsuitable for the study.
Major surgery within 6 months prior to dosing, planned surgery during the study, or previous surgery that may significantly affect the pharmacokinetics or safety evaluation of the study drug.
Current oral diseases that may affect the study, as judged by the investigator (e.g., oropharyngeal candidiasis, oral ulcers, oral mucosal lesions).
Fever (body temperature > 37.5°C) or symptomatic respiratory infection within 1 month prior to dosing; any infection requiring systemic antibiotics or antivirals within 3 months prior to screening; or a history of recurrent infections.
Trial design
Design model
Parallel
Treatments tested in this trial
ICF004
DrugParticipants in the Single Ascending Dose (SAD) part will receive a single dose of ICF004 via dry powder inhaler. There are 5 planned dose cohorts (1, 4, 8, 12, and 16 mg).
Placebo
DrugParticipants in the Single Ascending Dose (SAD) part will receive a single dose of matching placebo via dry powder inhaler.
ICF004
DrugParticipants in the Multiple Ascending Dose (MAD) part will receive multiple doses of ICF004 via dry powder inhaler. The doses will be administered once daily (QD) or twice daily (BID). There are 4 planned cohorts. The exact dose levels will be determined based on the safety and tolerability results from Part 1.
Pacebo
DrugParticipants in the Multiple Ascending Dose (MAD) part will receive multiple doses of matching placebo via dry powder inhaler, administered once daily (QD) or twice daily (BID).
Treatment groups
73 Participants
are divided into 4 treatment groupsGroup A: Part 1 (SAD): ICF004Experimental treatment 1 intervention
Group B: Part 1 (SAD): PlaceboPlacebo comparator 1 intervention
Group C: Part 2 (MAD): ICF004Experimental treatment 1 intervention
Group D: Part 2 (MAD): PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent adverse event (TEAE) is an adverse event that begins or worsens after the first dose of ICF004 or placebo. Safety assessments include local irritation symptoms, clinical laboratory tests, 12-lead electrocardiograms, pulmonary function tests, vital signs, and physical examinations. Clinically significant abnormal findings may be recorded as adverse events, as determined by the investigator.
Time frame
Day 1 through Day 7 for SAD and Day 1 through Day 14 for MADSecondary outcomes
1
Cmax: Maximum Observed Plasma Concentration After a Single Dose
Plasma pharmacokinetic (PK) parameter of ICF004 in healthy Chinese participants after a single inhaled dose.
Time frame
Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.2
Tmax: Time to Maximum Observed Plasma Concentration After a Single Dose
Plasma pharmacokinetic (PK) parameter of ICF004 in healthy Chinese participants after a single inhaled dose.
Time frame
Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.3
AUC0-t: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Concentration After a Single Dose
Plasma pharmacokinetic (PK) parameter of ICF004 in healthy Chinese participants after a single inhaled dose.
Time frame
Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.4
AUC0-♾️: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity After a Single Dose
Plasma pharmacokinetic (PK) parameter of ICF004 in healthy Chinese participants after a single inhaled dose.
Time frame
Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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