NCT05195723

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

A Phase 1a, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Overlapping Single and Multiple Ascending Dose Escalation Study of WP1122 to Establish Maximum Tolerated Dose and Evaluate Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Moleculin Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	WP1122	Oral solution
DRUG	Placebo	Oral solution

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-10-24
• Completion: 2022-10-24
• First posted: 2022-01-19
• Last updated: 2023-02-27

Locations

1 site across 1 country: United Kingdom