The Safety and PK Study of Inhaled ICF004 in Healthy Chinese Volunteers

NCT07719218 | Not Yet Recruiting Phase 1

• 1 other identifier: nIC004-202508
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Interstitial Lung Disease (ILD); Healthy Volunteers

Outcome Measures

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.

  Day 1 through Day 7 for SAD and Day 1 through Day 14 for MAD

Secondary Outcomes (28)

• Cmax: Maximum Observed Plasma Concentration After a Single Dose

  Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.

• Tmax: Time to Maximum Observed Plasma Concentration After a Single Dose

  Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.

• AUC0-t: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Concentration After a Single Dose

  Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.

• AUC0-♾️: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity After a Single Dose

  Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.

• t1/2z: Terminal Elimination Half-Life After a Single Dose

  Predose; 5, 10, 20, 30, and 45 minutes; and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.

Study Arms (4)

Part 1 (SAD): ICF004

EXPERIMENTAL

Drug: ICF004

Part 1 (SAD): Placebo

PLACEBO COMPARATOR

Drug: Placebo

Part 2 (MAD): ICF004

EXPERIMENTAL

Drug: ICF004

Part 2 (MAD): Placebo

PLACEBO COMPARATOR

Drug: Pacebo

Interventions

Placebo DRUG

Participants in the Single Ascending Dose (SAD) part will receive a single dose of matching placebo via dry powder inhaler.

Part 1 (SAD): Placebo

ICF004 DRUG

Participants 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).

Part 1 (SAD): ICF004

Pacebo DRUG

Participants 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).

Part 2 (MAD): Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Able to use the inhalation device correctly and effectively.
• Agree to use effective contraceptive measures throughout the study period. Female participants of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. During this period, female participants must agree to have no plans for pregnancy or egg donation/harvesting; male participants must agree to have no plans to father a child or donate sperm. Their male or female partners of childbearing potential must also agree to use effective contraceptive measures during this period.

You may not qualify if:

• 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.
• Positive test results for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen (HBsAg), Treponema pallidum (syphilis) antibody, or Hepatitis C Virus (HCV) antibody.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin exceeding the upper limit of normal (ULN) at the screening or baseline visit.
• Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) \< 80% of the predicted value, or FEV1/FVC \< 0.7, or arterial oxygen saturation \< 95% at the screening or baseline visit.
• Smoking (including e-cigarettes) within 6 months prior to dosing, or a positive smoking (nicotine/cotinine) test.
• History of drug abuse within 3 months prior to screening, or a positive urine drug screen.
• Participation in any drug or medical device clinical trial within 3 months prior to screening.
• Blood donation or blood loss ≥ 400 mL within 3 months prior to dosing.
• Difficulty in venous blood sampling, intolerance to venipuncture, or a history of needle or blood phobia (vasovagal syncope).
• Known allergy to the study drug or any of its ingredients.
• Female participants who are pregnant or lactating, or who plan to become pregnant from the time of the study through 6 months after the last dose.
• Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

PACEBO protocol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jingya Zhao, Ph.D

CONTACT

86-21-64370045; jingya2010@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share