Study of JMKX003948 Ophthalmic Suspension in Healthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJemincare
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Any abnormal examination with clinical significance may interfere with study evaluations in opinion of the Investigator (or medically qualified designee).
History of eye trauma or surgery including LASIK/LASEK.
Any corrected visual acuity < 20/20, or intraocular pressure ≥ 21 mmHg.
Trial design
Design model
Sequential
Treatments tested in this trial
JMKX003948 Ophthalmic Suspension
DrugJMKX003948 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
DrugJMKX003948 Ophthalmic Suspension placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: JMKX003948 Ophthalmic SuspensionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs)
Incidence of Adverse events (AEs)
Time frame
From Day1 to up to Day142
Number of Participants With abnormal Ophthalmic examination
Change from baseline of ophthalmic examination
Time frame
From Day1 to up to Day14Secondary outcomes
1
Maximum concentration (Cmax)
Cmax was the highest concentration observed directly from data
Time frame
From Day1 to up to Day142
Area under the concentration-time curve
Reflects the actual body exposure to drug after administration of sinlge and multiple dose
Time frame
From Day1 to up to Day143
Time to Cmax (Tmax)
Tmax was the time to reach maximum observed plasma concentration
Time frame
From Day1 to up to Day144
Elimination half-life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame
From Day1 to up to Day14Locations
Source ClinicalTrials.gov
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