NCT04704232

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

December 22, 2020

Last Update Submit

November 8, 2021

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    5 days

  • Visual analog scale rating of laser induced pain

    5 days

  • Number and percentage of subjects with adverse events

    5 days

  • +1 more other outcomes

Study Arms (2)

ACD440

ACTIVE COMPARATOR

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

Drug: ACD440

Placebo

PLACEBO COMPARATOR

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

Drug: PLAC

Interventions

ACD440DRUG

Double blind, parallel within subject comparison

ACD440
PLACDRUG

Double blind, parallel within subject comparison

Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer
  • Fitzpatrick skin type II or III
  • Women not childbearing potential or highly effective contraception

You may not qualify if:

  • Pregnancy, lactation
  • Drug abuse
  • Clinically significant illness
  • Positive COVID 19 test at screening or COVID 19 infection in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlzeCure Pharma investigational site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Pain

Interventions

5'-palmitoyl cytarabine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

January 11, 2021

Study Start

January 12, 2021

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)