Study of JMKX003948 Ophthalmic Suspension in Healthy Participants

NCT06832657 | Not Yet Recruiting Phase 1

• 1 other identifier: JMKX003948-101
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Age-Related Macular Degeneration (AMD); Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  Incidence of Adverse events (AEs)

  From Day1 to up to Day14

• Number of Participants With abnormal Ophthalmic examination

  Change from baseline of ophthalmic examination

  From Day1 to up to Day14

Secondary Outcomes (4)

• Maximum concentration (Cmax)

  From Day1 to up to Day14

• Area under the concentration-time curve

  From Day1 to up to Day14

• Time to Cmax (Tmax)

  From Day1 to up to Day14

• Elimination half-life (t1/2)

  From Day1 to up to Day14

Study Arms (2)

JMKX003948 Ophthalmic Suspension

EXPERIMENTAL

Drug: JMKX003948 Ophthalmic Suspension

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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)

JMKX003948 Ophthalmic Suspension

Placebo DRUG

JMKX003948 Ophthalmic Suspension placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jemincare: lead

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Medical Mabager

CONTACT

+8613761964261; shiyingyun@jemincere.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: February 18, 2025
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share