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

NCT07719218 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-07-22

No results posted yet for this study

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

Interventions

DRUG

ICF004

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).

DRUG

Placebo

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

DRUG

ICF004

Participants 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.

DRUG

Pacebo

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).

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2029-07-30
Completion
2029-07-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07719218 on ClinicalTrials.gov