drugset / Trial / NCT03301298

Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers

NCT03301298 ↗

Phase 1 Completed 48 enrolled Promentis Pharmaceuticals, Inc. Celerion · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

Timeline

Start
2017-09-11
Primary completion
2018-02-13
Completion
2018-02-13

Drugs

EvaluationDrugModalityDoseRoute
Subject SXC-2023 Unknown 50 mg Oral
Subject SXC-2023 Unknown 100 mg Oral
Subject SXC-2023 Unknown 200 mg Oral
Subject SXC-2023 Unknown 400 mg Oral
Subject SXC-2023 Unknown 800 mg Oral
Subject SXC-2023 Unknown 1600 mg Oral

Indications

No indication recorded.