Cognition DisorderEarly Phase 1NCT05783830
Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856
A Early Phase 1 study testing ACD856 in people with Cognition Disorder and Alzheimer Disease, run by AlzeCure Pharma at 1 site in Sweden.
Trial summary
This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorder, Alzheimer Disease
- What is being tested?
- ACD856
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 13 Jan 2020to 18 Apr 2020
- Phase
- Early 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males aged >18 and <65 years.
- Signed and dated informed consent prior to any study-mandated procedure
- Willing and able to comply with study requirements.
- BMI >18.0 and <30.0 kg/m^2
- Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
Who cannot join
- History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any planned major surgery within the duration of the study.
- Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
- Regular use of any prescribed or non-prescribed medication
- Planned treatment or treatment with another investigational drug within 3 months
Show all 13Show fewer
- Current smokers or users of nicotine products.
- Positive screen for drugs of abuse or alcohol at screening
- History of alcohol abuse or excessive intake of alcohol
- Presence or history of drug abuse
- History of, or current use of, anabolic steroids.
- Excessive caffeine consumption
- Plasma donation within one month of screening or blood donation during the 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers
This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.
- Conditions
- Cognition Disorder, Alzheimer Disease
- Being tested
- ACD856
- Keywords
- Cognition Disorder, Alzheimer's Disease
- Medical subject headings
- Cognition Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACD856Drug
IV injection 100 mcg
| Study group | Role | What they receive |
|---|---|---|
| ACD856 | Experimental | Not described Receives: Drug: ACD856 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration vs time curve from time zero extrapolated to infinity
a pharmacokinetic measure of the amount of study medication present in the blood
Measured: 24 hours
AUC from time zero to time of last quantifiable analyte concentration
a pharmacokinetic measure of the amount of study medication present in the blood
Measured: 96 hours
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Measured: 24 hours
Total body clearance following iv administration
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Measured: 24 hours
Volume of distribution following iv administration
a theoretical estimate of how much of the study drug that the body may contain
Measured: 24 hours
Secondary outcomes (4)
Number of subjects with adverse events
how many participants have reported a drug related advers event
Measured: 5 days
Number of subjects with clinically significant changes in vital signs
how many participants have had any clinically significant changes in vital signs
Measured: 5 days
Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)
how many participants have had study drug related changes to cardiac function
Measured: 5 days
Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis
how many participants have had study drug related changes in laboratory test analyses
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 posted24 Mar 2023
- Study start13 Jan 2020
- Primary completion18 Apr 2020
- Study completion18 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlzeCure Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Sandin, Study director, AlzeCure Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783830
- Sponsor's protocol ID
- D2000C0-001
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nilsson B, Bylund J, Halldin MM, Rother M, Rein-Hedin E, Onnestam K, Segerdahl M. ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics. Eur J Clin Pharmacol. 2024 May;80(5):717-727. doi: 10.1007/s00228-024-03645-1. Epub 2024 Feb 14.
PubMed 38353689
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05783830
- Acronym / sponsor ID
- D2000C0-001
- Conditions
- Cognition Disorder, Alzheimer Disease
- Keywords
- Cognition Disorder, Alzheimer's Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AlzeCure PharmaIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 24 Mar 2023 (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.
This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACD856 | Experimental | Drug: ACD856 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy males aged >18 and <65 years.
- Signed and dated informed consent prior to any study-mandated procedure
- Willing and able to comply with study requirements.
- BMI >18.0 and <30.0 kg/m^2
- Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
Key exclusion criteria (13 listed)
- History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any planned major surgery within the duration of the study.
- Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
- Regular use of any prescribed or non-prescribed medication
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 |
|---|---|---|
| ACD856IV injection 100 mcg | Drug | ACD856 |
Primary outcome
Area under the plasma concentration vs time curve from time zero extrapolated to infinity
Time frame: 24 hours
a pharmacokinetic measure of the amount of study medication present in the blood
AUC from time zero to time of last quantifiable analyte concentration
Time frame: 96 hours
a pharmacokinetic measure of the amount of study medication present in the blood
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
Time frame: 24 hours
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Total body clearance following iv administration
Time frame: 24 hours
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Volume of distribution following iv administration
Time frame: 24 hours
a theoretical estimate of how much of the study drug that the body may contain
4 secondary outcomes
Number of subjects with adverse events
Time frame: 5 days
Number of subjects with clinically significant changes in vital signs
Time frame: 5 days
Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)
Time frame: 5 days
Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis
Time frame: 5 days
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 24 Mar 2023.
- Derived from this study: PubMed 38353689Nilsson B, Bylund J, Halldin MM, Rother M, Rein-Hedin E, Onnestam K, Segerdahl M. ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics. Eur J Clin Pharmacol. 2024 May;80(5):717-727. doi: 10.1007/s00228-024-03645-1. Epub 2024 Feb 14.
- 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.
Johan Sandin study director
AlzeCure Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ACD856 in people with Cognition Disorder and Alzheimer Disease, 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 6 inclusion and 13 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 24 Mar 2023. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Area under the plasma concentration vs time curve from time zero extrapolated to infinity (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05783830, which also lists 1 linked publication.
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 24 Mar 2023.