Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers

AlzeCure Pharma

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: PLAC; Drug: ACD440

Study type: Interventional

Funder types: Industry

Identifiers

NCT04704232

D8000CI-001

Details and patient eligibility

About

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

Full description

This is an exploratory study, no primary or secondary endpoints are being defined.

Enrollment: 24 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

ACD440

Active Comparator group

Description:

Subjects are simultaneously exposed to topical administration of ACD440 in a crossover design in separate locations from the placebo exposure.

Treatment:

Drug: ACD440

Placebo

Placebo Comparator group

Description:

Subjects are simultaneously exposed to topical administration of placebo in a crossover design in separate locations from the ACD440 exposure.

Treatment:

Drug: PLAC