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

NCT06406348 | Completed Phase 1 FDA Drug

• 1 other identifier: ALIA-1758-101
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)

  Up to 85 days after dosing

Secondary Outcomes (6)

• 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

Study Arms (2)

Active

EXPERIMENTAL

Single Ascending Dose (SAD) cohorts

Drug: ALIA-1758

Placebo

PLACEBO COMPARATOR

Single Ascending Dose (SAD) cohorts

Other: Placebo

Interventions

ALIA-1758 DRUG

Intravenous or subcutaneous doses

Active

Placebo OTHER

Intravenous or subcutaneous doses

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• J. Michael Ryan, M.D.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 9, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)