Dry EyePhase 1NCT07521748
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants
A Phase 1 study testing RC017 Ophthalmic Ointment in people with Dry Eye, run by Nanjing Reju Therapeutics Co., Ltd.
Trial summary
This is a Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants.RC017 is a small-molecule drug, being developed as a novel therapeutic… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- RC017 Ophthalmic Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 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
- Healthy male and female trial participants aged 18 to 55 years old (inclusive);
- Body Mass Index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive), with body weight ≥ 50 kg for males and ≥ 45 kg for females;
- At screening, best corrected visual acuity (BCVA) of both eyes should be ≥ 1.0; in addition, ophthalmic examinations (including assessment of ocular symptoms, slit-lamp microscopy/external eye examination, corneal fluorescein staining, funduscopy, and intraocular pressure measurement) should show no abnormalities in both eyes, or any abnormalities detected should be judged as clinically insignificant by the investigator;
- Have a full understanding of the trial procedures, voluntarily participate in the trial, and sign a written informed consent form (ICF);
- Female participants with childbearing potential must have a negative result in the serum pregnancy test at screening. Throughout the entire study period and within 3 months after the study conclusion, all female participants, male participants and their sexual partners must agree to adopt effective contraceptive measures (Note: Contraceptive measures include both pharmacological and non-pharmacological methods, see Appendix 4 for details).
Who cannot join
- History of ocular diseases deemed by the investigator as unsuitable for enrollment, including but not limited to dry eye, glaucoma, blepharitis, meibomianitis, allergic conjunctivitis, iritis, uveitis, and/or active ocular inflammation or infection.
- Prior history of ocular surgeries, including laser refractive surgery and intraocular surgery, etc.
- Participants who wore contact lenses or cosmetic colored contact lenses within 2 weeks prior to screening, or those requiring contact lens wear during the trial.
- Use of any prescription or over-the-counter (OTC) medications (including vitamins, antacids, Chinese herbal medicines, dietary supplements, and topical ophthalmic drugs) within 2 weeks prior to screening.
- Clinically significant abnormalities in vital signs, physical examination findings, laboratory test results (complete blood count [CBC], urine routine, blood biochemistry, coagulation function, infectious disease screening, serum pregnancy test [females only]) or 12-lead electrocardiogram (ECG), as judged by the investigator.
- History of diseases involving the central nervous, mental, cardiovascular, renal, hepatic, respiratory, metabolic, or musculoskeletal systems, which in the investigator's judgment may compromise participant safety or interfere with study results.
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- Clinically significant history of allergies, especially drug allergies, or known hypersensitivity to any component of the study drug.
- Daily cigarette smoking > 5 sticks within 3 months prior to the trial.
- Suspected or confirmed alcohol dependence; average daily alcohol intake > 2 units within 3 months (1 unit = 10 mL pure ethanol, equivalent to 200 mL beer [5% alcohol], 25 mL spirits [40% alcohol], or 83 mL wine [12% alcohol]); or positive alcohol test result.
- History of drug abuse; or positive urine test for ketamine, morphine, methamphetamine, MDMA, or tetrahydrocannabinol carboxylic acid (THC-COOH).
- Participation in another clinical trial within 3 months prior to screening.
- Blood donation or blood loss ≥ 400 mL within 3 months prior to screening.
- Pregnant or lactating females.
- Unsuitability for venous blood collection.
- Vaccination within 30 days prior to screening, or planned vaccination during the study period.
- Any other conditions deemed by the investigator as unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants
This is a Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants.RC017 is a small-molecule drug, being developed as a novel therapeutic treatment for patients with Dry Eye Disease (DED) . This study aims to evaluate the safety, tolerability and pharmacokinetics of RC017 after Single and Multiple Doses.
- Conditions
- Dry Eye
- Being tested
- RC017 Ophthalmic Ointment, RC017 Ophthalmic Ointment placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC017 Ophthalmic OintmentDrug
Participants were randomly assigned to the 3 dose groups
RC017 Ophthalmic Ointment placeboDrug
Match to RC017 Ophthalmic Ointment dose groups
| Study group | Role | What they receive |
|---|---|---|
| RC017 Ophthalmic Ointment | Experimental | Not described Receives: Drug: RC017 Ophthalmic Ointment |
| RC017 Ophthalmic Ointment placebo | Placebo comparator | Not described Receives: Drug: RC017 Ophthalmic Ointment 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 to Day 21
The severity of Treatment-emergent adverse events (TEAEs)
Measured: Day 1-Day 21
The incidence of Serious adverse events (SAEs)
Measured: Day 1-Day 21
The severity of Serious adverse events (SAEs)
Measured: Day 1-Day 21
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Measured: Day 1-Day 21
Number of participants with abnormal clinically significant clinical laboratory results
Measured: Day 1- Day 21
Number of patients with abnormal clinically significant results from physical examination
Measured: Day 1-Day 21
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 posted13 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- 24 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
- NCT07521748
- Sponsor's protocol ID
- RC017-CN101
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07521748
- Acronym / sponsor ID
- RC017-CN101
- Conditions
- Dry Eye
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nanjing Reju Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 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 Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of RC017 Ophthalmic Ointment Following Single and Multiple Doses in Healthy Adult Participants.RC017 is a small-molecule drug, being developed as a novel therapeutic treatment for patients with Dry Eye Disease (DED) . This study aims to evaluate the safety, tolerability and pharmacokinetics of RC017 after Single and Multiple Doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC017 Ophthalmic Ointment | Experimental | Drug: RC017 Ophthalmic Ointment |
| RC017 Ophthalmic Ointment placebo | Placebo comparator | Drug: RC017 Ophthalmic Ointment placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female trial participants aged 18 to 55 years old (inclusive);
- Body Mass Index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive), with body weight ≥ 50 kg for males and ≥ 45 kg for females;
- At screening, best corrected visual acuity (BCVA) of both eyes should be ≥ 1.0; in addition, ophthalmic examinations (including assessment of ocular symptoms, slit-lamp microscopy/external eye examination, corneal fluorescein staining, funduscopy, and intraocular pressure measurement) should show no abnormalities in both eyes, or any abnormalities detected should be judged as clinically insignificant by the investigator;
- Have a full understanding of the trial procedures, voluntarily participate in the trial, and sign a written informed consent form (ICF);
- Female participants with childbearing potential must have a negative result in the serum pregnancy test at screening. Throughout the entire study period and within 3 months after the study conclusion, all female participants, male participants and their sexual partners must agree to adopt effective contraceptive measures (Note: Contraceptive measures include both pharmacological and non-pharmacological methods, see Appendix 4 for details).
Key exclusion criteria (16 listed)
- History of ocular diseases deemed by the investigator as unsuitable for enrollment, including but not limited to dry eye, glaucoma, blepharitis, meibomianitis, allergic conjunctivitis, iritis, uveitis, and/or active ocular inflammation or infection.
- Prior history of ocular surgeries, including laser refractive surgery and intraocular surgery, etc.
- Participants who wore contact lenses or cosmetic colored contact lenses within 2 weeks prior to screening, or those requiring contact lens wear during the trial.
- Use of any prescription or over-the-counter (OTC) medications (including vitamins, antacids, Chinese herbal medicines, dietary supplements, and topical ophthalmic drugs) within 2 weeks prior to screening.
- Clinically significant abnormalities in vital signs, physical examination findings, laboratory test results (complete blood count [CBC], urine routine, blood biochemistry, coagulation function, infectious disease screening, serum pregnancy test [females only]) or 12-lead electrocardiogram (ECG), as judged by the investigator.
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 |
|---|---|---|
| RC017 Ophthalmic OintmentParticipants were randomly assigned to the 3 dose groups | Drug | RC017 Ophthalmic Ointment |
| RC017 Ophthalmic Ointment placeboMatch to RC017 Ophthalmic Ointment dose groups | Drug | RC017 Ophthalmic Ointment placebo |
Primary outcome
The incidence of Treatment-emergent adverse events (TEAEs)
Time frame: Day1 to Day 21
The severity of Treatment-emergent adverse events (TEAEs)
Time frame: Day 1-Day 21
The incidence of Serious adverse events (SAEs)
Time frame: Day 1-Day 21
The severity of Serious adverse events (SAEs)
Time frame: Day 1-Day 21
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time frame: Day 1-Day 21
Number of participants with abnormal clinically significant clinical laboratory results
Time frame: Day 1- Day 21
Number of patients with abnormal clinically significant results from physical examination
Time frame: Day 1-Day 21
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RC017 Ophthalmic Ointment in people with Dry Eye, run by Nanjing Reju Therapeutics Co., Ltd.
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 5 inclusion and 16 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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 to Day 21). 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 13 Apr 2026.