New inhaled drug for lung disease tested in healthy people first
NCT ID NCT07528703
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new inhaled drug called RC010 in 42 healthy adults in China. The main goal is to check if it is safe and how the body processes it. This drug is being developed for a serious lung condition called idiopathic pulmonary fibrosis (IPF), but this study does not involve people with the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 2. Aged between 18 and 55 years inclusive, of both genders; 3. 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; 4. 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: 1. 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. 2. 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. 3. Has a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, or similar conditions. 4. 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. 5. 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. 6. Suffered from lower respiratory tract infection, or upper respiratory tract infection requiring antibiotic therapy, within 6 weeks prior to screening/enrollment. 7. 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. 8. Received any live vaccine (excluding influenza vaccine) within 30 days prior to screening, or plans to receive vaccines during the study period. 9. Has a history of drug allergies, specific allergic conditions (e.g., asthma, urticaria, eczema), is an atopic individual (allergic to ≥2 types of drugs/foods/pollen), or has a known allergy to any component of RC010 Inhalation Powder. 10. Lost blood or donated blood \> 400 mL within 3 months prior to screening (excluding female menstrual blood loss), or intends to donate blood during the study or within 1 month post-study. 11. Underwent surgery within 1 month prior to screening, or plans to undergo surgery during the study period. 12. Excessively consumed tea, coffee, or caffeinated beverages (average ≥ 8 cups/day, 250 mL/cup) within 6 months prior to screening. 13. Ingested caffeine/xanthine-containing products (e.g., coffee, tea, cola, chocolate), poppy seed-containing foods, or CYP2C8/CYP3A4-affecting substances (e.g., limes, grapefruit/juice, pomelos) within 48 hours prior to investigational product administration. 14. Used hepatic drug-metabolizing enzyme inhibitors/inducers within 28 days prior to screening; or used prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 14 days prior to screening. For long half-life drugs, the washout period shall be at least 5 times the drug half-life. 15. Has special dietary requirements and cannot comply with the unified study diet. 16. Has venous blood collection difficulties, or a history of needle phobia/hematophobia. 17. Is a heavy smoker (smoking ≥ 5 cigarettes/day within 3 months prior to the first dose), cannot comply with smoking prohibition during the study, or has a positive smoking test result. 18. Has a history of regular alcohol consumption within 6 months prior to screening (women \> 14 standard units/week, men \> 21 standard units/week; 1 unit = 14g alcohol), cannot abstain from alcohol during the study, or has a positive breath alcohol test result. 19. Has a history of drug abuse, or has a positive drug abuse screening result (including benzodiazepines, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol carboxylic acid). 20. Has clinically significant abnormal findings in screening physical examination, vital signs, laboratory tests (blood/urine/stool routine, biochemistry, coagulation, thyroid function, etc.), abdominal B-ultrasound, or chest X-ray, as judged by the investigator. 21. Has positive screening results for HBsAg, anti-HCV, TPPA, or HIV-Ag/Ab. 22. Has screening pulmonary function test results showing FEV₁/predicted value ≤ 80%, FVC ≤ 80% of predicted value, or other clinically significant abnormalities. 23. Is a pregnant/lactating woman, or has a positive screening blood pregnancy test result. 24. Has clinically significant abnormal 12-lead ECG findings at screening (e.g., bradycardia/tachycardia, QTcF ≥ 450 ms \[male\]/≥ 470 ms \[female\], arrhythmia), as judged by the investigator. 25. Has screening serum potassium concentration \< 3.5 mmol/L. 26. Is unwilling/unable to correctly use the inhaler for investigational product administration, or fails inhalation training. 27. Is deemed unsuitable for study participation due to other circumstances judged by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
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Other studies related to the condition(s) this trial covers.
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