Alzheimer DiseasePhase 1NCT06511570
A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants
A Phase 1 study testing sabirnetug (ACU193) and Sabirnetug + rHuPH20 in people with Alzheimer Disease, run by Acumen Pharmaceuticals at 1 site in United States.
Trial summary
A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- sabirnetug (ACU193) and Sabirnetug + rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 17 Sep 2024
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily consents to participate in this study and provides written informed consent before the start of any study assessments.
- Male and female participants ≥ 50 years of age.
- Females must be of non-childbearing potential, defined as:
- Postmenopausal females must have had ≥12 months of spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) ≥40 milli international units (mIU)/mL) or
- Surgically sterile including those who have had a hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation at least 6 months before the first dose of the study drug.
- Body mass index (BMI) between 18 and 32 kg/m2 (inclusive), and weighs ≥54 kg.
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- Screening vital signs (measured after participants have rested in a supine position for a minimum of 5 minutes) within the following ranges: heart rate: 40-100 beats per minute (bpm); systolic blood pressure (BP): 90-150 millimeter of mercury (mmHg); diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once at any time point during the study per Investigator discretion.
- Sperm-producing males in a sexual relationship with females of childbearing potential (FOCBPs) must use adequate contraception (e.g., condom) and must not donate sperm, starting from Screening until 180 days after the last dose of the study drug (See Section 5.3).
- Must be willing to abstain from smoking while confined at the CTU.
- The participant is confirmed to have adequate venous access by study staff.
- Is willing and able to remain in the CTU for the entire duration of each confinement period and return for outpatient visits.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
- Shows signs/symptoms of dementia or has a parent with a known autosomal dominant mutation causing familial AD.
- A clinically significant abnormal finding on the physical exam, medical history, clinical laboratory results or electrocardiogram (ECG), or at Screening. The Investigator may repeat clinical laboratory tests once to assess any out-of-range values for clinical significance.
- Participants with a value >2.5 times the upper limit of normal (ULN) or <60% the lower limit of normal (LLN) or any other value of concern per the Investigator will be excluded.
- QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval is >460ms in females, QTcF>450ms in males and has ECG findings considered normal or not clinically significant by the Investigator or designee at Screening.
- Suicide risk, as determined by meeting any of the following criteria:
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- Any suicide attempt or preparatory acts/behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening in the last six months.
- Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening.
- Significant risk of suicide, as judged by the site Investigator.
- Known allergy to biological products or known hypersensitivity to any component of sabirnetug or hyaluronidase, including excipients.
- Use of any experimental agent within 6 months of the first dose of study drug.
- Administration of vaccinations (e.g., SARS-CoV-2 [COVID-19], influenza) within 14 days of administration of the study drug.
- Use of any over the counter (OTC) medication, nutritional or dietary supplements, homeopathic preparations, herbal remedies such as St. John's Wort Extract, or vitamins within 14 days before the first dose of the study drug until EOS without evaluation and approval by the Investigator.
- Use of any prescription medication, starting from 14 days or 5 half-lives (whichever is longer) prior to the first dose of the study drug until EOS without evaluation and approval by the Investigator.
- Blood or plasma donation within 7 days before the first dose of the study drug until EOS. Blood/plasma donations should not be made for at least 90 days after the last dose of the study drug.
- Has any prior history of substance abuse or treatment (including alcohol) within the 2 years prior to the first study treatment administration.
- Regular alcohol consumption >14 units per week (1 unit=½ pint beer, 25 mL of 40% spirit or a 125-mL glass of wine).
- Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates), cotinine, or alcohol.
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- Documented COVID-19 active infection or recent COVID-19 infection in the past 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study Comparing the Safety, Tolerability, and Pharmacokinetics of Single-Dose Intravenous Sabirnetug (ACU193) and Multiple-Dose Subcutaneous Sabirnetug (ACU193) + rHuPH20 in Healthy Participants
A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants
- Conditions
- Alzheimer Disease
- Being tested
- sabirnetug (ACU193), Sabirnetug + rHuPH20
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sabirnetug (ACU193)Drug
sabirnetug by intravenous infusion
Sabirnetug + rHuPH20Combination product
sabirnetug + rHuPH20 by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 12 participants receive sabirnetug by intravenous infusion Receives: Drug: sabirnetug (ACU193) |
| Arm 2 | Experimental | 16 participants receive sabirnetug + rHuPH20 by subcutaneous injection Receives: Combination Product: Sabirnetug + rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate blood levels of sabirnetug (ACU193)
Cmax (Maximum concentration, determined directly from individual concentration-time data)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate time to reach maximum blood levels of sabirnetug (ACU193)
Tmax (Time of the maximum concentration)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), terminal rate
λz (The observed terminal rate constant; estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate time to reach half-life blood levels of sabirnetug (ACU193), half-life
T1/2 (The observed terminal half-life)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), concentration-time
AUC168h (Area under the concentration-time curve during a one-week dosing interval)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), last concentration-time
AUClast (Area under the concentration-time curve from time zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), infinity concentration-time
AUCinf (Area under the concentration-time curve from time zero extrapolated to infinity)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), extrapolation
AUCExtrap (%)(The percentage of AUCinf based on extrapolation)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), Clast
Clast (The last quantifiable concentration determined directly from individual concentration-time data)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate time to reach last blood levels of sabirnetug (ACU193)
Tlast (Time of the last quantifiable concentration)
Measured: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start25 Jun 2024
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acumen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Siemers, M.D., Study director, Acumen Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511570
- Sponsor's protocol ID
- ACU193-102
- Status last verified
- Oct 2024
- First submitted
- 8 Jul 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study Comparing the Safety, Tolerability, and Pharmacokinetics of Single-Dose Intravenous Sabirnetug (ACU193) and Multiple-Dose Subcutaneous Sabirnetug (ACU193) + rHuPH20 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06511570
- Acronym / sponsor ID
- ACU193-102
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Acumen PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 22 Jul 2024 (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.
A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: sabirnetug (ACU193)12 participants receive sabirnetug by intravenous infusion |
| Arm 2 | Experimental | Combination Product: Sabirnetug + rHuPH2016 participants receive sabirnetug + rHuPH20 by subcutaneous injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily consents to participate in this study and provides written informed consent before the start of any study assessments.
- Male and female participants ≥ 50 years of age.
- Females must be of non-childbearing potential, defined as:
- Body mass index (BMI) between 18 and 32 kg/m2 (inclusive), and weighs ≥54 kg.
- Screening vital signs (measured after participants have rested in a supine position for a minimum of 5 minutes) within the following ranges: heart rate: 40-100 beats per minute (bpm); systolic blood pressure (BP): 90-150 millimeter of mercury (mmHg); diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once at any time point during the study per Investigator discretion.
Key exclusion criteria (20 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
- Shows signs/symptoms of dementia or has a parent with a known autosomal dominant mutation causing familial AD.
- A clinically significant abnormal finding on the physical exam, medical history, clinical laboratory results or electrocardiogram (ECG), or at Screening. The Investigator may repeat clinical laboratory tests once to assess any out-of-range values for clinical significance.
- Suicide risk, as determined by meeting any of the following criteria:
- Known allergy to biological products or known hypersensitivity to any component of sabirnetug or hyaluronidase, including excipients.
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 |
|---|---|---|
| sabirnetug (ACU193)sabirnetug by intravenous infusion | Drug | Arm 1 |
| Sabirnetug + rHuPH20sabirnetug + rHuPH20 by subcutaneous injection | Combination product | Arm 2 |
Primary outcome
Estimate blood levels of sabirnetug (ACU193)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Cmax (Maximum concentration, determined directly from individual concentration-time data)
Estimate time to reach maximum blood levels of sabirnetug (ACU193)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Tmax (Time of the maximum concentration)
Estimate blood levels of sabirnetug (ACU193), terminal rate
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
λz (The observed terminal rate constant; estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile)
Estimate time to reach half-life blood levels of sabirnetug (ACU193), half-life
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
T1/2 (The observed terminal half-life)
Estimate blood levels of sabirnetug (ACU193), concentration-time
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
AUC168h (Area under the concentration-time curve during a one-week dosing interval)
Estimate blood levels of sabirnetug (ACU193), last concentration-time
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
AUClast (Area under the concentration-time curve from time zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule)
Estimate blood levels of sabirnetug (ACU193), infinity concentration-time
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
AUCinf (Area under the concentration-time curve from time zero extrapolated to infinity)
Estimate blood levels of sabirnetug (ACU193), extrapolation
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
AUCExtrap (%)(The percentage of AUCinf based on extrapolation)
Estimate blood levels of sabirnetug (ACU193), Clast
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Clast (The last quantifiable concentration determined directly from individual concentration-time data)
Estimate time to reach last blood levels of sabirnetug (ACU193)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Tlast (Time of the last quantifiable concentration)
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 18 Oct 2024.
- 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.
Eric Siemers, M.D. study director
Acumen Pharmaceuticals
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 sabirnetug (ACU193) and Sabirnetug + rHuPH20 in people with Alzheimer Disease, run by Acumen Pharmaceuticals at 1 site in United States.
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 11 inclusion and 20 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 18 Oct 2024. 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 United States. 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?
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?
Estimate blood levels of sabirnetug (ACU193) (time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50). The study lists 10 primary outcomes in all. 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 18 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.