A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 19 - 55 |
Updated: | 5/16/2018 |
Start Date: | August 2016 |
End Date: | May 8, 2018 |
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
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
in healthy volunteers conducted at one study center in the United States
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.
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.
Inclusion Criteria:
1. Understands the study procedures in the informed consent form (ICF), and be willing
and able to comply with the protocol.
2. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of
age, inclusive, at screening.
Exclusion Criteria:
1. Subject is mentally or legally incapacitated or has significant emotional problems at
the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the PI.
3. History of any illness that, in the opinion of the PI, might confound the results of
the study or poses an additional risk to the subject by their participation in the
study.
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