NCT06406348CompletedPhase 1
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
AbbVie1 site in 1 country53 target enrollmentStarted: May 9, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Active
Experimental
Single Ascending Dose (SAD) cohorts
Intervention: ALIA-1758 (Drug)
Placebo
Placebo Comparator
Single Ascending Dose (SAD) cohorts
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax(0-85 days after dosing)
- Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2(0-85 days after dosing)
- Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC(0-85 days after dosing)
- Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability(0-85 days after dosing)
- Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance(0-85 days after dosing)
- Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution(0-85 days after dosing)
Investigators
Study Sites (1)
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Related News
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- ALIA-1758, currently in Phase I trials, is an anti-pyroglutamate amyloid beta antibody designed to degrade and eliminate amyloid plaques, a hallmark of Alzheimer's disease.
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- Aliada's lead asset, ALIA-1758, an anti-pyroglutamate amyloid beta antibody for Alzheimer's disease, is currently in Phase 1 clinical trials.
- The acquisition strengthens AbbVie's neuroscience portfolio and enhances its R&D capabilities for developing next-generation neurological therapies.
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