Study of JMKX003948 Ophthalmic Suspension in Healthy Participants

Launched by JEMINCARE · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new eye treatment called JMKX003948 Ophthalmic Suspension to see if it is safe and well-tolerated by healthy participants. The treatment is being tested in different strengths (1%, 2%, 3%, and 5%) compared to a placebo, which is a dummy treatment that contains no active medication. The study will involve healthy adults aged 18 to 45 who meet specific health criteria. Participants will be monitored closely at a medical facility for about two weeks after receiving the treatment.

To be eligible for this trial, participants need to be healthy adults with a body mass index (BMI) between 18 and 32 and must not have any serious medical conditions that could affect their safety or the study's results. Women who can become pregnant and sexually active men will need to use effective birth control during the study. It's important to note that this trial is not yet recruiting participants, so anyone interested will need to wait until it starts. Overall, this study aims to provide valuable information about the safety of this new treatment for eye conditions like Age-Related Macular Degeneration and Diabetic Macular Edema.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy adult males and/or females, 18 to 45 years of age (inclusive) at the date of signed consent form.
• • 2. Body mass index (BMI) greater than or equal to 18 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
• • 3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
• • 4. 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.
• Exclusion Criteria:
• • 1. 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.
• • 2. Any abnormal examination with clinical significance may interfere with study evaluations in opinion of the Investigator (or medically qualified designee).
• • 3. History of eye trauma or surgery including LASIK/LASEK.
• • 4. Any corrected visual acuity \< 20/20, or intraocular pressure ≥ 21 mmHg.
• • 5. 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).