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

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ClinicalTrials.gov Identifier: NCT04704232
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
AlzeCure Pharma

Study Description
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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

Condition or disease Intervention/treatment Phase
Pain Drug: ACD440 Phase 1

Detailed Description:
This is an exploratory study, no primary or secondary endpoints are being defined.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective,Double-blind,Randomized,Placebo-controlled Study of Safety,Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ACD440 Drug: ACD440
Double blind, parallel within subject comparison
Placebo Comparator: Placebo Drug: ACD440
Double blind, parallel within subject comparison


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704232


Contacts
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Contact: Johan Sandin, CSO +46703738824 info@alzecurepharma.com

Locations
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Sweden
AlzeCure Pharma investigational site Recruiting
Stockholm, Sweden
Contact: Johan Sandin, PhD       info@alzecurepharma.com   
Sponsors and Collaborators
AlzeCure Pharma
More Information
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Responsible Party: AlzeCure Pharma
ClinicalTrials.gov Identifier: NCT04704232    
Other Study ID Numbers: D8000CI-001
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No