drugset / Trial / NCT05983939

Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers

NCT05983939 ↗

Phase 1 Completed 56 enrolled Contineum Therapeutics
RandomizedSequentialTriple-blindTreatment

Summary

This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD), Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a fed state. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE).

Timeline

Start
2023-06-26
Primary completion
2024-02-01
Completion
2024-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PIPE-791 Small molecule — Oral

Indications