PainPhase 1NCT04704232
Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
A Phase 1 study testing ACD440 and PLAC in people with Pain, run by AlzeCure Pharma at 1 site in Sweden.
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 Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- ACD440 and PLAC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 12 Jan 2021to 10 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Fitzpatrick skin type II or III
- Women not childbearing potential or highly effective contraception
Who cannot join
- Pregnancy, lactation
- Drug abuse
- Clinically significant illness
- Positive COVID 19 test at screening or COVID 19 infection in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
This is an exploratory study, no primary or secondary endpoints are being defined.
- Conditions
- Pain
- Being tested
- ACD440, PLAC
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACD440Drug
Double blind, parallel within subject comparison
PLACDrug
Double blind, parallel within subject comparison
| Study group | Role | What they receive |
|---|---|---|
| ACD440 | Active comparator | Subjects are simultaneously exposed to topical administration of ACD440 in a crossover design in separate locations from the placebo exposure. Receives: 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. Receives: Drug: PLAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start12 Jan 2021
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlzeCure Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704232
- Sponsor's protocol ID
- D8000CI-001
- Status last verified
- Nov 2021
- First submitted
- 22 Dec 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective,Double-blind,Randomized,Placebo-controlled Study of Safety,Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04704232
- Acronym / sponsor ID
- D8000CI-001
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AlzeCure PharmaIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACD440 | Active comparator | Drug: ACD440Subjects are simultaneously exposed to topical administration of ACD440 in a crossover design in separate locations from the placebo exposure. |
| Placebo | Placebo comparator | Drug: PLACSubjects are simultaneously exposed to topical administration of placebo in a crossover design in separate locations from the ACD440 exposure. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteer
- Fitzpatrick skin type II or III
- Women not childbearing potential or highly effective contraception
Key exclusion criteria (4 listed)
- Pregnancy, lactation
- Drug abuse
- Clinically significant illness
- Positive COVID 19 test at screening or COVID 19 infection in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACD440Double blind, parallel within subject comparison | Drug | ACD440 |
| PLACDouble blind, parallel within subject comparison | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACD440 and PLAC in people with Pain, run by AlzeCure Pharma at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser-evoked potentials as a tool for assessing the efficacy of antinociceptive drugs (time frame: 5 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.