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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06406348

Enrollment

Registered

2024-05-09

Start date

2024-05-09

Completion date

2025-04-22

Last updated

2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

DRUGALIA-1758

Intravenous or subcutaneous doses

OTHERPlacebo

Intravenous or subcutaneous doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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: Cmax	0-85 days after dosing	Cmax
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)
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability	0-85 days after dosing	Bioavailability after SC administration (F)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026