Alzheimer DiseasePhase 1NCT06406348
A Phase 1 Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy Participants
A Phase 1 study testing ALIA-1758 in people with Alzheimer Disease, run by AbbVie at 1 site in United States.
Trial summary
This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- ALIA-1758
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to 22 Apr 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must understand the nature of the trial and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any trial-related procedures.
- Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG) recording. A participant with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the participant, (b) will not interfere with trial procedures or confound trial results, and (c) is not otherwise exclusionary (see Exclusion Criteria).
- Body weight of at least 50.0 kg for men and 45.0 kg for women and Body Mass Index (BMI) within the range of 17.5-32.0 kg/m2 (inclusive) at Screening.
Who cannot join
- A history or presence of a clinically significant hepatic, biliary, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, psychiatric, neurologic abnormality, or chronic urinary tract infections.
- A clinically significant abnormality on physical examination, ECG, or laboratory evaluations at Screening or between Screening and (first) dose administration.
- The participant is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the protocol or is unsuitable for any reason.
- Other criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, 78217
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single Ascending Dose Trial to Assess the Safety, Tolerability and Pharmacokinetic Effects of ALIA-1758 in Healthy Participants
This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants.
- Conditions
- Alzheimer Disease
- Being tested
- ALIA-1758, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIA-1758Drug
Intravenous or subcutaneous doses
PlaceboOther
Intravenous or subcutaneous doses
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Single Ascending Dose (SAD) cohorts Receives: Drug: ALIA-1758 |
| Placebo | Placebo comparator | Single Ascending Dose (SAD) cohorts Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
Measured: Up to 85 days after dosing
Secondary outcomes (6)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax
Cmax
Measured: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2
elimination half-life (T1/2)
Measured: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC
Area Under Curve (AUC)
Measured: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability
Bioavailability after SC administration (F)
Measured: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance
Clearance (CL)
Measured: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution
Volume of distribution (Vz)
Measured: 0-85 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start9 May 2024
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
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.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Michael Ryan, M.D., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406348
- Sponsor's protocol ID
- ALIA-1758-101
- Status last verified
- Jul 2025
- First submitted
- 6 May 2024
- Last updated
- 17 Jul 2025
- Results posted
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single Ascending Dose Trial to Assess the Safety, Tolerability and Pharmacokinetic Effects of ALIA-1758 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06406348
- Acronym / sponsor ID
- ALIA-1758-101
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 9 May 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.
This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected ALIA-1758 in healthy male and female participants.
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 |
|---|---|---|
| Active | Experimental | Drug: ALIA-1758Single Ascending Dose (SAD) cohorts |
| Placebo | Placebo comparator | Other: PlaceboSingle Ascending Dose (SAD) cohorts |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must understand the nature of the trial and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any trial-related procedures.
- Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG) recording. A participant with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the participant, (b) will not interfere with trial procedures or confound trial results, and (c) is not otherwise exclusionary (see Exclusion Criteria).
- Body weight of at least 50.0 kg for men and 45.0 kg for women and Body Mass Index (BMI) within the range of 17.5-32.0 kg/m2 (inclusive) at Screening.
Key exclusion criteria (4 listed)
- A history or presence of a clinically significant hepatic, biliary, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, psychiatric, neurologic abnormality, or chronic urinary tract infections.
- A clinically significant abnormality on physical examination, ECG, or laboratory evaluations at Screening or between Screening and (first) dose administration.
- The participant is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the protocol or is unsuitable for any reason.
- Other criteria may apply
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 |
|---|---|---|
| ALIA-1758Intravenous or subcutaneous doses | Drug | Active |
| PlaceboIntravenous or subcutaneous doses | Other | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 85 days after dosing
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
6 secondary outcomes
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance
Time frame: 0-85 days after dosing
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution
Time frame: 0-85 days after dosing
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 17 Jul 2025.
- 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.
J. Michael Ryan, M.D. study director
AbbVie
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 ALIA-1758 in people with Alzheimer Disease, run by AbbVie 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 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 17 Jul 2025. 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. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 85 days after dosing). 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 17 Jul 2025.