A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants

NCT07528703 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: RC010-CN101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

IPF

Outcome Measures

Primary Outcomes (7)

• The incidence of Treatment-emergent adverse events (TEAEs)

  Day1-Day14

• The severity of Treatment-emergent adverse events (TEAEs)

  Day 1-Day 14

• The incidence of Serious adverse events (SAEs)

  Day 1-Day 14

• The severity of Serious adverse events (SAEs)

  Day 1- Day 14

• Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters

  Day 1-Day 14

• Number of participants with abnormal clinically significant clinical laboratory results

  Day 1- Day 14

• Number of patients with abnormal clinically significant results from physical examination

  Day 1-Day 14

Secondary Outcomes (5)

• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Day 1-Day 14

• AUC from time zero to infinity (AUC0-∞)

  Day 1-Day 14

• Maximum observed concentration (Cmax)

  Day 1-Day 14

• Time of maximum observed concentration (Tmax)

  Day 1 - Day 14

• Terminal elimination half life(t1/2)

  Day 1-Day 14

Study Arms (2)

RC010 Inhalation Powder

EXPERIMENTAL

RC010 Inhalation Powder：01.mg、0.3mg、0.75mg、1.5mg and 2mg，Single-dose administration

Drug: RC010 Inhalation Powder

RC010 Inhalation Powder placebo

EXPERIMENTAL

RC010 Inhalation Powder placebo：0mg，Single-dose administration

Drug: RC010 Inhalation Powder placebo

Interventions

RC010 Inhalation Powder DRUG

Participants were randomly assigned to the 0.1, 0.3, 0.75, 1.5 and 2 mg dose groups

RC010 Inhalation Powder

RC010 Inhalation Powder placebo DRUG

Match to RC010 Inhalation Powder dose groups

RC010 Inhalation Powder placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Underwent surgery within 1 month prior to screening, or plans to undergo surgery during the study period.
• Excessively consumed tea, coffee, or caffeinated beverages (average ≥ 8 cups/day, 250 mL/cup) within 6 months prior to screening.
• 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.
• 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.
• Has special dietary requirements and cannot comply with the unified study diet.

Sponsors & Collaborators

• Nanjing Reju Therapeutics Co., Ltd: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Central Study Contacts

Minghong Shang

CONTACT

+86-15366078819; minghongshang@rejutec.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)