NCT06832657Not yet recruitingPhase 1
Study of JMKX003948 Ophthalmic Suspension in Healthy Participants
A Randomized, Double-blind, Placebo-controlled Phase 1 Study of JMKX003948 Ophthalmic Suspension to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) in Healthy Participants
Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study is a randomized, double-blind, placebo-controlled, phase 1 study of JMKX003948 Ophthalmic Suspension to evaluate the safety, tolerability and PK of single and multiple ascending doses in healthy participants. Participant will be randomized to receive either JMKX003948 Ophthalmic Suspension (1%, 2%, 3% or 5%) or matching placebo (JMKX003948 Ophthalmic Suspension: placebo= 6: 2, N=8 per cohort). Five cohorts (Cohort 1-5) are planned. Cohorts could also de-escalate to a lower concentration if current formulation was not tolerated (Cohort 1b, 2b and 3b). In case of de-escalation, Cohort 1b and 2b will continue to escalate to Cohort 1c and Cohort 2c, respectively. Participants will be admitted to the site on Day -1 after screening (up to 28 days), and remain domiciled until Day 14 for Cohort 1-4, Day 8 for other cohorts.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 25 Dec 2024
- Start date
- Feb 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- Jemincare
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT06832657
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From Feb 2025 to the primary completion date, Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of disease of ocular surface, fundus, central nervous system, psychiatric and psychological condition, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system, or other disease that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with study evaluations.
- History of eye trauma or surgery including LASIK/LASEK.
Other
- Any abnormal examination with clinical significance may interfere with study evaluations in opinion of the Investigator (or medically qualified designee).
- Any corrected visual acuity \< 20/20, or intraocular pressure ≥ 21 mmHg.
- Clinically significant abnormalities on ophthalmic examination that would hinder the assessment of the eye or data collection at the discretion of the Investigator and/or ophthalmologist (or medically qualified designee).
Who the study is looking for
- Healthy adult males and/or females, 18 to 45 years of age (inclusive) at the date of signed consent form.
- Body mass index (BMI) greater than or equal to 18 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- Women of child-bearing potential and sexually active males willing to use highly effective methods of contraception from screening until 3 months after last dose of study drug. In addition, participants must not donate sperm/egg for the time period specified above.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.