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

pH Pharma1 site in 1 country49 target enrollmentAugust 2, 2018

ConditionsHealthy Volunteer

InterventionsPHP-303 Placebo

DrugsPHP-303

Overview

Phase: Phase 1
Intervention: PHP-303
Conditions: Healthy Volunteer
Sponsor: pH Pharma
Enrollment: 49
Locations: 1
Primary Endpoint: Plasma concentration of single oral dose of PHP-303 - t1/2
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2, 2018

End Date

January 8, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

pH Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects, ≥ 18 to ≤ 55 years of age.
•In good general health having no clinically significant diseases in medical history or evidence of clinically significant findings on physical examination, vital signs, laboratory results, and/or ECG at Screening, in the opinion of an Investigator.
•Willing to forego other forms of experimental treatment during the study.

Exclusion Criteria

•Any clinically significant condition that, in the opinion of an Investigator, could preclude the safe participation of the subject in the study or would prevent the subject from meeting the study requirements.
•Major surgery in the 6 months preceding Screening.
•Clinically-significant abnormal laboratory parameters.
•Positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine, tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at Screening or on admission to the study site.
•Electrocardiographic Fridericia's corrected QT interval (QTcF) interval \> 450 msec for males and \> 470 msec for females, or any other clinically significant electrocardiographic abnormality.
•Blood pressure results \> 150 mmHg systolic or \> 95 mmHg diastolic
•Female subject who is pregnant (positive pregnancy test at the Screening Visit or on admission to the study site), lactating, or planning to become pregnant during the study period or within 3 months after the final dose of study medication.
•History of drug or alcohol abuse or dependence within 1 year prior to Screening.
•History of cigarette smoking within 3 months of Screening.
•Known intolerance to lactose.