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drugset / Trial / NCT03627845

A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects

NCT03627845 ↗

Phase 1 Completed 49 enrolled pH Pharma
RandomizedSequentialDouble-blindTreatment

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in healthy volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 3:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability of orally-administered PHP-303.

Timeline

Start
2018-08-02
Primary completion
2018-12-05
Completion
2020-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject PHP-303 Unknown — Oral

Indications

No indication recorded.