Pain
Conditions
Brief summary
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
Detailed description
This is an exploratory study, no primary or secondary endpoints are being defined.
Interventions
DRUGACD440
Double blind, parallel within subject comparison
DRUGPLAC
Double blind, parallel within subject comparison
Sponsors
AlzeCure Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteer * Fitzpatrick skin type II or III * Women not childbearing potential or highly effective contraception
Exclusion criteria
* Pregnancy, lactation * Drug abuse * Clinically significant illness * Positive COVID 19 test at screening or COVID 19 infection in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs | 5 Days | Not defined as primary as per protocol, but system does not seem to allow omittance of primaries |
Other
| Measure | Time frame | Description |
|---|---|---|
| Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs | 5 days | Exploratory efficacy endpoint |
| Visual analog scale rating of laser induced pain | 5 days | Exploratory efficacy endpoint |
| Number and percentage of subjects with adverse events | 5 days | Safety endpoint |
| Number and percentage of subjects with clinically significant changes in 12-lead ECGs, vital signs and laboratory findings | 5 days | Safety endpoint |
Countries
Sweden
Outcome results
None listed