A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring [ Time Frame: 16 days post dose ]
- Pharmacokinetic analysis: Area under the curve [ Time Frame: 16 days post dose ]
- Pharmacokinetic analysis: Maximum observed plasma drug concentration [ Time Frame: 16 days post dose ]
- Pharmacokinetic analysis: Time of maximum observed concentration [ Time Frame: 16 days post dose ]
|Study Start Date:||August 2016|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Three (3) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02858973
|Contact: June Kimfirstname.lastname@example.org|
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68502|
|Contact: Jiye Ahn email@example.com|