Age-Related Macular Degeneration (AMD)Phase 1NCT06832657
Study of JMKX003948 Ophthalmic Suspension in Healthy Participants
A Phase 1 study testing JMKX003948 Ophthalmic Suspension in people with Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME), run by Jemincare.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME)
- What is being tested?
- JMKX003948 Ophthalmic Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Dec 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read more
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.
- Being tested
- JMKX003948 Ophthalmic Suspension, Placebo
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003948 Ophthalmic SuspensionDrug
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)
PlaceboDrug
JMKX003948 Ophthalmic Suspension placebo
| Study group | Role | What they receive |
|---|---|---|
| JMKX003948 Ophthalmic Suspension | Experimental | Not described Receives: Drug: JMKX003948 Ophthalmic Suspension |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of Adverse events (AEs)
Measured: From Day1 to up to Day14
Number of Participants With abnormal Ophthalmic examination
Change from baseline of ophthalmic examination
Measured: From Day1 to up to Day14
Secondary outcomes (4)
Maximum concentration (Cmax)
Cmax was the highest concentration observed directly from data
Measured: From Day1 to up to Day14
Area under the concentration-time curve
Reflects the actual body exposure to drug after administration of sinlge and multiple dose
Measured: From Day1 to up to Day14
Time to Cmax (Tmax)
Tmax was the time to reach maximum observed plasma concentration
Measured: From Day1 to up to Day14
Elimination half-life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: From Day1 to up to Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832657
- Sponsor's protocol ID
- JMKX003948-101
- Status last verified
- Feb 2025
- First submitted
- 25 Dec 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No