NCT03627845

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

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: pH Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	PHP-303	Investigational drug
OTHER	Placebo	Matching placebo

Timeline

• Start date: 2018-08-02
• Primary completion: 2018-12-05
• Completion: 2020-01-08
• First posted: 2018-08-13
• Last updated: 2020-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study