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OpenTrials
Completed

NCT Number: NCT04704232

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AlzeCure Pharma investigational site

Stockholm, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACD440

Drug

Double blind, parallel within subject comparison

PLAC

Drug

Double blind, parallel within subject comparison

Primary outcomes

  1. Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs

    Time frame: 5 Days

    Not defined as primary as per protocol, but system does not seem to allow omittance of primaries

Other outcomes

  1. Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs

    Time frame: 5 days

    Exploratory efficacy endpoint

  2. Visual analog scale rating of laser induced pain

    Time frame: 5 days

    Exploratory efficacy endpoint

  3. Number and percentage of subjects with adverse events

    Time frame: 5 days

    Safety endpoint

  4. Number and percentage of subjects with clinically significant changes in 12-lead ECGs, vital signs and laboratory findings

    Time frame: 5 days

    Safety endpoint

Sponsors and collaborators

Lead sponsor

AlzeCure Pharma

Industry

Registry information

Official study title

Prospective,Double-blind,Randomized,Placebo-controlled Study of Safety,Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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