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

Study Director
Dr. Kiyean Nam
Start Date
8 / 2015
Trial Phase
Phase I
Trial Status
in data analysis
Current Enrollment
Target Enrollment

Experimental: Q203 drug products (10mg and 100mg tablets)

Placebo Comparator: Placebo tablets (same excipients used in Q203 drug products)

Fasting: 10, 30, 50,100, 150, 200, 400, 800 mg/kg

With Food: 100 mg/kg

Phase 1. Description from  Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, receiving either Q203 or placebo (6 active treatment : 2 placebo) in a fasting state. Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a cohort, completes all procedures and none of the subjects has a clinically significant adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related serious adverse events (SAEs) have occurred. A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100 mg dose level (this dose level may change based on PK analysis results). Subjects who received 100mg dose in a fasting state will return and receive the second dose, with food. Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.

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