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)
NCT Number: NCT06832657
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From Day1 to up to Day14
Incidence of Adverse events (AEs)
Time frame: From Day1 to up to Day14
Change from baseline of ophthalmic examination
Time frame: From Day1 to up to Day14
Cmax was the highest concentration observed directly from data
Time frame: From Day1 to up to Day14
Reflects the actual body exposure to drug after administration of sinlge and multiple dose
Time frame: From Day1 to up to Day14
Tmax was the time to reach maximum observed plasma concentration
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.
Contact information is provided by the study sponsor or research team.
Jemincare
Industry
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07456826
Age-related Macular Degeneration (AMD), Cardiovascular Diseases
Tyler, Texas, United States
View Trial DetailsNCT02585401
Age-related Macular Degeneration (AMD), Cardiovascular Diseases
Many Locations, Canada
View Trial DetailsNCT05780931
Age-related Macular Degeneration (AMD), Eye Diseases
Augusta, Georgia, United States
View Trial DetailsNCT07249307
Age-related Macular Degeneration (AMD), Cardiovascular Diseases
View Trial Details