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
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