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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406348
• Other study ID #: ALIA-1758-101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Aliada Therapeutics
• Contact: This is a single site clinical trial.
• Phone: 210-635-1515
• Email: participate[@]worldwide.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• ALIA-1758
Intravenous or subcutaneous doses

Other:
• Placebo
Intravenous or subcutaneous doses

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials Early Phase Services, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aliada Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Cmax	Cmax	0-85 days after dosing
Secondary	Pharmacokinetic parameters of ALIA-1758 in healthy subjects: T1/2	elimination half-life (T1/2)	0-85 days after dosing
Secondary	Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC	Area Under Curve (AUC)	0-85 days after dosing
Secondary	Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability	Bioavailability after SC administration (F)	0-85 days after dosing
Secondary	Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance	Clearance (CL)	0-85 days after dosing
Secondary	Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Volume of distribution	Volume of distribution (Vz)	0-85 days after dosing