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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704232
• Other study ID #: D8000CI-001
• Status: Completed
• Phase: Phase 1
• Start date: January 12, 2021
• Est. completion date: March 10, 2021

Study information

• Verified date: November 2021
• Source: AlzeCure Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• ACD440
Double blind, parallel within subject comparison
• PLAC
Double blind, parallel within subject comparison

Locations

Country	Name	City	State
Sweden	AlzeCure Pharma investigational site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AlzeCure Pharma

Country where clinical trial is conducted

Sweden, 

Outcome

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