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

Prospective,Double-blind,Randomized,Placebo-controlled 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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: ACD440; Drug: PLAC

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • AlzeCure Pharma investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ACD440; Subjects are simultaneously exposed to topical administration of ACD440 in a crossover design in separate locations from the placebo exposure.	Drug: ACD440; Double blind, parallel within subject comparison
PLACEBO_COMPARATOR: Placebo; Subjects are simultaneously exposed to topical administration of placebo in a crossover design in separate locations from the ACD440 exposure.	Drug: PLAC; Double blind, parallel within subject comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs	Not defined as primary as per protocol, but system does not seem to allow omittance of primaries	5 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs	Exploratory efficacy endpoint	5 days
Visual analog scale rating of laser induced pain	Exploratory efficacy endpoint	5 days
Number and percentage of subjects with adverse events	Safety endpoint	5 days
Number and percentage of subjects with clinically significant changes in 12-lead ECGs, vital signs and laboratory findings	Safety endpoint	5 days

Collaborators and Investigators

• Sponsor: AlzeCure Pharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2021
• Primary Completion (ACTUAL): March 10, 2021
• Study Completion (ACTUAL): March 10, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (ACTUAL): January 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: D8000CI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No