drugset / Trial / NCT05195723

Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers

NCT05195723 ↗

Phase 1 Completed 48 enrolled Moleculin Biotech, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study in healthy human volunteers will investigate the effects of a single dose (SAD) and multiple days of dosing (MAD) of WP1122 administered as an oral (PO) solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and PK, and subsequent clinical development will be in patients infected with SARS CoV-2 in the setting of continued safety and favorable risk/benefit.

Timeline

Start
2022-05-11
Primary completion
2022-10-24
Completion
2022-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject WP1122 Small molecule — Oral

Indications

No indication recorded.