A Phase 1 Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy Participants

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: ALIA-1758; Other: Placebo

• Registration Number: NCT06406348
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study Start: 2024-05-09
• Study First Posted: 2024-05-09
• Primary Completion: 2025-04-22
• Study Completion: 2025-04-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	ALIA-1758	Single Ascending Dose (SAD) cohorts
Placebo	Placebo	Single Ascending Dose (SAD) cohorts

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 85 days after dosing	Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax	0-85 days after dosing	Cmax
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2	0-85 days after dosing	elimination half-life (T1/2)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC	0-85 days after dosing	Area Under Curve (AUC)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability	0-85 days after dosing	Bioavailability after SC administration (F)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance	0-85 days after dosing	Clearance (CL)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution	0-85 days after dosing	Volume of distribution (Vz)

Trial Locations

Locations (1)

Worldwide Clinical Trials Early Phase Services, LLC; 🇺🇸 San Antonio, Texas, United States