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This will be a double masked, randomized, placebo controlled, single and multiple oral dose study conducted in 3 parts. The safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young and older adult subjects will be evaluated. The study will also characterize the pharmacokinetic (PK) profile of QA102 in plasma and urine after single and multiple oral doses of QA102. Besides, the metabolite profile of QA102 will also be characterized.
Part 1 will comprise a single dose, sequential cohort design. Part 2 will comprise a multiple dose, sequential cohort study. Part 3 will comprise a multiple dose, single cohort study in older subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QA102 group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QA102 | Drug | Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of QA102 capsules), oral administration, single dose. Intervention of Part 2: 2 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration. Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events | To evaluate the safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young adult and elderly subjects. | Up to 7 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12] | up to 12 hours postdose | |
| Maximum observed plasma concentration [Cmax] | Up to 48 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| renal clearance (CLR ) | up to 24 hours postdose | |
| Metabolite characterization of QA102 | To characterize metabolites of QA102 in plasma samples after multiple oral doses of QA102 in healthy adult subjects. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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|
| Placebo | Drug | Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of Placebo capsules), oral administration, single dose. Intervention of Part 2: 2 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration. Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration. |
|
| time of the maximum observed plasma concentration [tmax] | up to 48 hours postdose |
| Within 24 hours after last dose |