drugset / Trial / NCT03775278

A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects

NCT03775278 ↗

Phase 1 Completed 50 enrolled pH Pharma
RandomizedSequentialDouble-blindTreatment

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.

Timeline

Start
2018-12-17
Primary completion
2019-07-24
Completion
2020-04-07

Drugs

EvaluationDrugModalityDoseRoute
Subject PHP-303 Unknown — Oral

Indications