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drugset / Trial / NCT04618263

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

NCT04618263 ↗

Phase 1 Terminated 18 enrolled Syndeio Biosciences, Inc
RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start
2020-10-26
Primary completion
2021-08-13
Completion
2021-08-13

Outcome

Outcome not reported

Stopped: “Reached biomarker endpoint”

Drugs

EvaluationDrugModalityDoseRoute
Subject GATE-101 Unknown 5 mg Intravenous
Subject GATE-101 Unknown 15 mg Intravenous
Subject GATE-101 Unknown 50 mg Intravenous
Subject GATE-101 Unknown 150 mg Intravenous
Subject GATE-101 Unknown 450 mg Intravenous

Indications

hypersomnia major depressive disorder