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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q203 | Experimental | Q203 tablets |
|
| Placebo | Placebo Comparator | Placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q203 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring | 16 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic analysis: Area under the curve | 16 days post dose | |
| Pharmacokinetic analysis: Maximum observed plasma drug concentration | 16 days post dose | |
| Pharmacokinetic analysis: Time of maximum observed concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C584497 | telacebec |
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|
| 16 days post dose |