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NCT Number: NCT06832657

Study of JMKX003948 Ophthalmic Suspension in Healthy Participants

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

JMKX003948 Ophthalmic Suspension

Drug

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

Drug

JMKX003948 Ophthalmic Suspension placebo

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From Day1 to up to Day14

    Incidence of Adverse events (AEs)

  2. Number of Participants With abnormal Ophthalmic examination

    Time frame: From Day1 to up to Day14

    Change from baseline of ophthalmic examination

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: From Day1 to up to Day14

    Cmax was the highest concentration observed directly from data

  2. Area under the concentration-time curve

    Time frame: From Day1 to up to Day14

    Reflects the actual body exposure to drug after administration of sinlge and multiple dose

  3. Time to Cmax (Tmax)

    Time frame: From Day1 to up to Day14

    Tmax was the time to reach maximum observed plasma concentration

  4. Elimination half-life (t1/2)

    Time frame: From Day1 to up to Day14

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Mabager

CONTACT

[email protected]

+8613761964261

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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