IPFPhase 1NCT07528703
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants
A Phase 1 study testing RC010 Inhalation Powder in people with IPF, run by Nanjing Reju Therapeutics Co., Ltd at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- IPF
- What is being tested?
- RC010 Inhalation Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 27Show fewer
- 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.
- Has venous blood collection difficulties, or a history of needle phobia/hematophobia.
- 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.
- 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.
- Has a history of drug abuse, or has a positive drug abuse screening result (including benzodiazepines, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol carboxylic acid).
- 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.
- Has positive screening results for HBsAg, anti-HCV, TPPA, or HIV-Ag/Ab.
- Has screening pulmonary function test results showing FEV₁/predicted value ≤ 80%, FVC ≤ 80% of predicted value, or other clinically significant abnormalities.
- Is a pregnant/lactating woman, or has a positive screening blood pregnancy test result.
- 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.
- Has screening serum potassium concentration < 3.5 mmol/L.
- Is unwilling/unable to correctly use the inhaler for investigational product administration, or fails inhalation training.
- Is deemed unsuitable for study participation due to other circumstances judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Li, +86-15300059186, gcpljt@189.cn
About this study
Official title: A Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Chinese Participants
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
- Being tested
- RC010 Inhalation Powder, RC010 Inhalation Powder placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC010 Inhalation PowderDrug
Participants were randomly assigned to the 0.1, 0.3, 0.75, 1.5 and 2 mg dose groups
RC010 Inhalation Powder placeboDrug
Match to RC010 Inhalation Powder dose groups
| Study group | Role | What they receive |
|---|---|---|
| RC010 Inhalation Powder | Experimental | RC010 Inhalation Powder：01.mg、0.3mg、0.75mg、1.5mg and 2mg，Single-dose administration Receives: Drug: RC010 Inhalation Powder |
| RC010 Inhalation Powder placebo | Experimental | RC010 Inhalation Powder placebo：0mg，Single-dose administration Receives: Drug: RC010 Inhalation Powder placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Treatment-emergent adverse events (TEAEs)
Measured: Day1-Day14
The severity of Treatment-emergent adverse events (TEAEs)
Measured: Day 1-Day 14
The incidence of Serious adverse events (SAEs)
Measured: Day 1-Day 14
The severity of Serious adverse events (SAEs)
Measured: Day 1- Day 14
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Measured: Day 1-Day 14
Number of participants with abnormal clinically significant clinical laboratory results
Measured: Day 1- Day 14
Number of patients with abnormal clinically significant results from physical examination
Measured: 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))
Measured: Day 1-Day 14
AUC from time zero to infinity (AUC0-∞)
Measured: Day 1-Day 14
Maximum observed concentration (Cmax)
Measured: Day 1-Day 14
Time of maximum observed concentration (Tmax)
Measured: Day 1 - Day 14
Terminal elimination half life(t1/2)
Measured: Day 1-Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Reju Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528703
- Sponsor's protocol ID
- RC010-CN101
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07528703
- Acronym / sponsor ID
- RC010-CN101
- Conditions
- IPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Nanjing Reju Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC010 Inhalation Powder | Experimental | Drug: RC010 Inhalation PowderRC010 Inhalation Powder：01.mg、0.3mg、0.75mg、1.5mg and 2mg，Single-dose administration |
| RC010 Inhalation Powder placebo | Experimental | Drug: RC010 Inhalation Powder placeboRC010 Inhalation Powder placebo：0mg，Single-dose administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC010 Inhalation PowderParticipants were randomly assigned to the 0.1, 0.3, 0.75, 1.5 and 2 mg dose groups | Drug | RC010 Inhalation Powder |
| RC010 Inhalation Powder placeboMatch to RC010 Inhalation Powder dose groups | Drug | RC010 Inhalation Powder placebo |
Primary outcome
The incidence of Treatment-emergent adverse events (TEAEs)
Time frame: Day1-Day14
The severity of Treatment-emergent adverse events (TEAEs)
Time frame: Day 1-Day 14
The incidence of Serious adverse events (SAEs)
Time frame: Day 1-Day 14
The severity of Serious adverse events (SAEs)
Time frame: Day 1- Day 14
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time frame: Day 1-Day 14
Number of participants with abnormal clinically significant clinical laboratory results
Time frame: Day 1- Day 14
Number of patients with abnormal clinically significant results from physical examination
Time frame: Day 1-Day 14
5 secondary outcomes
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Day 1-Day 14
AUC from time zero to infinity (AUC0-∞)
Time frame: Day 1-Day 14
Maximum observed concentration (Cmax)
Time frame: Day 1-Day 14
Time of maximum observed concentration (Tmax)
Time frame: Day 1 - Day 14
Terminal elimination half life(t1/2)
Time frame: Day 1-Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for IPF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RC010 Inhalation Powder in people with IPF, run by Nanjing Reju Therapeutics Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghong Shang (+86-15366078819, minghongshang@rejutec.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Treatment-emergent adverse events (TEAEs) (time frame: Day1-Day14). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.