ALIA-1758 Safety Study in Healthy Participants

Overseen By Olutola Adetona, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Aliada Therapeutics

Disqualifiers: Hepatic, Renal, Cardiovascular, Psychiatric, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

52 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

J. Michael Ryan, M.D.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy men and women who are interested in helping to test a new drug called ALIA-1758, which could potentially be used for Alzheimer's disease. The details of the specific eligibility criteria have not been provided.

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

Participants must be 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)

I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 17.5 and 32.

Exclusion Criteria

I have a significant health issue affecting my organs or immune system.

Participant is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the protocol or is unsuitable for any reason

I have no significant health issues found in recent tests or exams.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of ALIA-1758 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics after dosing

12 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• ALIA-1758

Trial Overview The study is testing the safety and how well the body handles a single dose of ALIA-1758, given either through an IV or as a shot under the skin. Participants will be randomly assigned to receive either ALIA-1758 or a placebo without knowing which one they get.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

Single Ascending Dose (SAD) cohorts

Group II: Placebo Placebo Group 1 Intervention

Single Ascending Dose (SAD) cohorts

Who Is Running the Clinical Trial?

Aliada Therapeutics

Lead Sponsor

Trials

1

Recruited

50+

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois