Clinical trial NCT06406348: A Phase 1 Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-05-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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.

Key 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 85 days after dosing
Secondary outcomes:
measure: Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax
timeFrame: 0-85 days after dosing
measure: Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2
timeFrame: 0-85 days after dosing
measure: Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC
timeFrame: 0-85 days after dosing
measure: Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability
timeFrame: 0-85 days after dosing
measure: Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance
timeFrame: 0-85 days after dosing
measure: Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution
timeFrame: 0-85 days after dosing
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services, LLC
state: Texas
Study officials:
affiliation: AbbVie
name: J. Michael Ryan, M.D.
role: STUDY_DIRECTOR
References: