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Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects
Sponsor: MIRA Pharmaceuticals
Summary
This is a prospective, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of oral Ketamir-2 in healthy adult participants. The study includes single ascending dose cohorts and multiple ascending dose cohorts.
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2025-03-20
Completion Date
2026-03-05
Last Updated
2026-08-27
Healthy Volunteers
Yes
Conditions
Interventions
Ketamir-2
Ketamir-2, also referred to as Ketamir hemipamoate, was administered orally as capsules containing 50 mg or 300 mg. Participants randomized to active treatment received Ketamir-2 according to assigned dose cohort. Cohorts 1 through 4 received a single dose on Day 1. Cohorts 5 through 7 received once-daily dosing from Day 1 through Day 5. Capsules were swallowed together with a glass of water after an overnight fast.
Placebo
Placebo capsules were identical in appearance to active capsules and were administered orally according to the same number of capsules and dosing schedule as the corresponding Ketamir-2 dose cohort.
Locations (1)
Hadassah Clinical Research Unit
Jerusalem, Israel