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

NCT ID: NCT04704232

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2021-03-10

Brief Summary

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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

Detailed Description

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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ACD440

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

Group Type ACTIVE_COMPARATOR

ACD440

Intervention Type DRUG

Double blind, parallel within subject comparison

Placebo

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

Group Type PLACEBO_COMPARATOR

PLAC

Intervention Type DRUG

Double blind, parallel within subject comparison

Interventions

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ACD440

Double blind, parallel within subject comparison

Intervention Type DRUG

PLAC

Double blind, parallel within subject comparison

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AlzeCure Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AlzeCure Pharma investigational site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D8000CI-001

Identifier Type: -

Identifier Source: org_study_id