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Phase 1 b placebo-controlled study in healthy volunteers to study safety, efficacy and pharmacokinetics of Topical ACD440 on normal skin, skin optimized for penetration and skin exposed to ultraviolet radiation
This is an exploratory study, no primary or secondary endpoints are being defined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACD440 | Active Comparator | Subjects are simultaneously exposed to topical administration of ACD440 in a crossover design in separate locations from the placebo exposure. |
|
| Placebo | Placebo Comparator | Subjects are simultaneously exposed to topical administration of placebo in a crossover design in separate locations from the ACD440 exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACD440 | Drug | Double blind, parallel within subject comparison |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs | Not defined as primary as per protocol, but system does not seem to allow omittance of primaries | 5 Days |
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| Measure | Description | Time Frame |
|---|---|---|
| Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs | Exploratory efficacy endpoint | 5 days |
| Visual analog scale rating of laser induced pain | Exploratory efficacy endpoint |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AlzeCure Pharma investigational site | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008758 | 5'-palmitoyl cytarabine |
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| PLAC |
| Drug |
Double blind, parallel within subject comparison |
|
| 5 days |
| Number and percentage of subjects with adverse events | Safety endpoint | 5 days |
| Number and percentage of subjects with clinically significant changes in 12-lead ECGs, vital signs and laboratory findings | Safety endpoint | 5 days |