NCT05597241

Multiple Ascending Dose and Electroencephalography Trial of GATE-202 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Single Center Phase1 Study of Safety, Tolerability, Pharmacokinetics, and Electroencephalography of Intravenous GATE-202 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Syndeio Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, pharmacokinetics and EEG pharmacodynamics of single and multiple ascending doses of apimostinel in normal human volunteers

Detailed description

Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in normal human volunteers. Subjects will receive a single 25 mg IV dose of apimostinel or matching placebo, or 8 consecutive days of 1, 5, 10, or 25 mg IV or matching placebo.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	apimostinel	N-methyl-D-aspartate (NMDA) receptor modulator
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-10-15
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2022-10-28
• Last updated: 2023-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study