A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC01… (NCT07528703) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants
China42 participantsStarted 2026-04
Plain-language summary
This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of RC010 in healthy adult volunteers. RC010 is a small-molecule drug , being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability and pharmacokinetics of RC010 after Single ascending doses .
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Be able to communicate well with the researchers, fully understand the objectives and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form;
✓. Aged between 18 and 55 years inclusive, of both genders;
✓. Have a body mass index (BMI) between 19.0 kg/m² and 28.0 kg/m² inclusive, and a body weight of ≥ 50.0 kg for males or ≥ 45.0 kg for females;
✓. Have no plans for childbearing, sperm donation or egg donation from the time of voluntarily signing the informed consent form until 90 days after the last dose, and voluntarily adopt medically approved contraceptive measures (including their partners, see Appendix 1 for details).
Exclusion criteria
✕. Received clinical trial medication or participated in other medical research activities within 3 months prior to screening, and is deemed unsuitable for study enrollment by the investigator.
✕. Has a history of or currently suffers from clinically unstable diseases/abnormalities of the cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, infectious, hematological, nervous, or neuropsychiatric systems, which the investigator judges to interfere with study conduct.
✕. Has a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, or similar conditions.
✕. Has a history of severe oral/maxillofacial deformities, or presents with oral candidiasis, ulcers, or other mucosal lesions at screening that may affect oral inhalation administration.
What they're measuring
1
The incidence of Treatment-emergent adverse events (TEAEs)
Timeframe: Day1-Day14
2
The severity of Treatment-emergent adverse events (TEAEs)
Timeframe: Day 1-Day 14
3
The incidence of Serious adverse events (SAEs)
Timeframe: Day 1-Day 14
4
The severity of Serious adverse events (SAEs)
Timeframe: Day 1- Day 14
5
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Timeframe: Day 1-Day 14
6
Number of participants with abnormal clinically significant clinical laboratory results
Timeframe: Day 1- Day 14
7
Number of patients with abnormal clinically significant results from physical examination
. Has a past or current history of bleeding risk-increasing diseases (e.g., acute gastritis, active bleeding peptic ulcers), clinically significant thrombocytopenia/anemia (Hb \< 80 g/L and/or PLT \< 100×10⁹/L), active pathological bleeding, or intracranial hemorrhage history.
✕. Suffered from lower respiratory tract infection, or upper respiratory tract infection requiring antibiotic therapy, within 6 weeks prior to screening/enrollment.
✕. Has a history of chronic obstructive pulmonary disease (COPD) or other respiratory diseases, including but not limited to tuberculosis infection, α-1 antitrypsin deficiency, cystic fibrosis, symptomatic asthma, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary arterial hypertension, pulmonary edema, or interstitial lung disease.
✕. Received any live vaccine (excluding influenza vaccine) within 30 days prior to screening, or plans to receive vaccines during the study period.