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Not yet recruiting NCT06832657

Study of JMKX003948 Ophthalmic Suspension in Healthy Participants

Phase I Interventional Age-Related Macular Degeneration (AMD) Diabetic Macular Edema (DME)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JMKX003948 Ophthalmic Suspension, Placebo.
Who it may be relevant to
Registry conditions: Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME). Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug 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)
  • Drug Placebo
    JMKX003948 Ophthalmic Suspension placebo

Primary outcome measures

  • Adverse events (AEs) [Time frame: From Day1 to up to Day14]
  • Number of Participants With abnormal Ophthalmic examination [Time frame: From Day1 to up to Day14]
Secondary outcome measures (4)
  • Maximum concentration (Cmax) [Time frame: From Day1 to up to Day14]
  • Area under the concentration-time curve [Time frame: From Day1 to up to Day14]
  • Time to Cmax (Tmax) [Time frame: From Day1 to up to Day14]
  • Elimination half-life (t1/2) [Time frame: From Day1 to up to Day14]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06832657 · JMKX003948-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗