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

Launched by ABBVIE · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial, called a Phase 1 trial, is testing a new medication called ALIA-1758 to see if it is safe and how the body processes it. The trial involves healthy men and women aged 18 to 65, and participants will receive either ALIA-1758 or a placebo (a substance with no active medication) through an injection. The main goal is to find out if ALIA-1758 is tolerated well in the body and to gather information about how it behaves after being given.

To be eligible for this trial, participants need to be in good health according to a medical evaluation and meet certain weight and body mass index (BMI) requirements. They must also be able to understand the trial and give their written consent. During the trial, participants will undergo medical assessments to ensure they are healthy enough to participate. This study is important as it aims to gather early information that could help in developing treatments for Alzheimer's disease.

Gender

ALL

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