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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: PLAC; Drug: ACD440

• Registration Number: NCT04704232
• Lead Sponsor: AlzeCure Pharma

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.

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Study Start: 2021-01-12
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AlzeCure Pharma investigational site; 🇸🇪 Stockholm, Sweden