NCT02858973

A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers

A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Qurient Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States

Detailed description

Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort. Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events \[AEs\]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203. Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Q203
DRUG	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-05-01
• Completion: 2018-05-08
• First posted: 2016-08-08
• Last updated: 2018-05-14

Locations

1 site across 1 country: United States