Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers
NCT04618263 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2022-08-03
Summary
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers
Conditions
- Major Depressive Disorder
- Excessive Sleepiness
Interventions
- DRUG
-
GATE-101
GATE-101 is a metabotropic glutamate receptor type 2/3 antagonist
Sponsors & Collaborators
-
Syndeio Biosciences, Inc
lead INDUSTRY
Principal Investigators
-
Ronald M Burch, MD, PhD · Syndeio Biosciences, Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-26
- Primary Completion
- 2021-08-13
- Completion
- 2021-08-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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