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COMPLETED
NCT07791303
PHASE1

Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects

Sponsor: MIRA Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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