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Study of JMKX003948 Ophthalmic Suspension in Healthy Participants
Sponsor: Jemincare
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-02
Completion Date
2025-12
Last Updated
2025-02-18
Healthy Volunteers
Yes
Interventions
JMKX003948 Ophthalmic Suspension
JMKX003948 Ophthalmic Suspension with formulation 1% (15 mg/1.5 mL), 2% (30 mg/1.5 mL), 3% (45 mg/1.5 mL), 5% (75 mg/1.5 mL)
Placebo
JMKX003948 Ophthalmic Suspension placebo