NCT04618263

Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers

A Randomized Double-blind, Placebo-controlled Single and Multiple Intravenous Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of GATE-101 in Normal Healthy Volunteers

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

Summary

To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers

Detailed description

Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in normal human volunteers. Secondary objectives: To evaluate the pharmacokinetics (PK) of GATE-101 following increasing single and multiple doses of intravenously (IV) administered GATE-101. GATE-101 or Placebo: Dose/Mode of Administration: Single or 5 Daily Doses;Intravenous

Conditions

• Major Depressive Disorder
• Excessive Sleepiness

Interventions

Type	Name	Description
DRUG	GATE-101	GATE-101 is a metabotropic glutamate receptor type 2/3 antagonist

Timeline

• Start date: 2020-10-26
• Primary completion: 2021-08-13
• Completion: 2021-08-13
• First posted: 2020-11-05
• Last updated: 2022-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study