Study of JMKX003948 Ophthalmic Suspension in Healthy Participants
Status:
NOT_YET_RECRUITING
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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.