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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment called ALIA-1758 in healthy individuals. Researchers are administering ALIA-1758 to humans for the first time to observe how the body processes it when given through an IV or injection under the skin. The trial consists of two groups: one receives ALIA-1758, and the other receives a placebo (a harmless, inactive substance). Healthy individuals without significant medical issues, who can adhere to trial guidelines, are suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any significant medications. Please check with the trial organizers for specific guidance.

Is there any evidence suggesting that ALIA-1758 is likely to be safe for humans?

Research has shown that ALIA-1758 is under study to determine its safety and tolerability in healthy individuals. As this is an early-stage trial, detailed safety information remains limited. However, the primary goal of a Phase 1 trial is to ensure the treatment's safety for humans. In this phase, researchers typically test treatments at low doses to observe the body's response, helping to identify any potential side effects.

This phase often marks the first use of a new treatment in humans. While the focus remains on safety, detailed information about side effects is still being gathered. Researchers closely monitor participants for any adverse effects, which is crucial for ensuring safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ALIA-1758 because it offers a new approach to treatment by introducing a unique mechanism of action that distinguishes it from current standard treatments. Unlike existing options that typically focus on symptom management, ALIA-1758 targets the underlying pathways involved in the condition, potentially offering more effective and lasting relief. This innovative approach has the potential to improve patient outcomes and reduce side effects associated with traditional therapies.

What evidence suggests that ALIA-1758 could be effective?

Initial findings suggest that researchers are studying ALIA-1758 to understand its safety, tolerability, and pharmacokinetics when administered by injection. Participants in this trial will receive either ALIA-1758 or a placebo as part of the Single Ascending Dose (SAD) cohorts. The treatment remains in the early stages of research, so specific information on its efficacy for any particular condition is not yet available. However, it is being developed with an interest in Alzheimer's disease and brain health, indicating potential future use in these areas. Currently, the primary goal is to ensure its safety for people. Further studies will be necessary to determine its effectiveness in treating specific conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

J. Michael Ryan, M.D.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06406348?rank=1

Study Details | NCT06406348 | A Phase 1 Trial to Assess ... ... study that is assessed for biomedical or health outcomes ... Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy Participants.

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=ALIA-1758-101

A Phase 1 Trial to Assess Safety, Tolerability and ... This is a Phase 1, first in human, double-blind, placebo-controlled, single ascending dose trial to assess safety, tolerability, and pharmacokinetics of ALIA- ...

3. trialx.com trialx.com/clinical-trials/listings/292786/a-phase-1-trial-to-assess-safety-tolerability-and-pharmacokinetics-of-alia-1758-in-healthy-participants/

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

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12326716/

A manifesto for Alzheimer's disease drug discovery in the era ... Randomized phase II study of the safety and efficacy of semorinemab in participants with mild-to-moderate Alzheimer disease: lauriet.

5. news.abbvie.com news.abbvie.com/2024-10-28-AbbVie-to-Acquire-Aliada-Therapeutics,-Strengthening-Focus-in-Alzheimers-Disease-and-Neuroscience-Pipeline

AbbVie to Acquire Aliada Therapeutics, Strengthening ... This investigational candidate is currently in a Phase 1 clinical trial to assess its safety and tolerability in healthy participants ( ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06406348/

Trial | NCT06406348 A Phase 1 Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy Participants ... Report Data Issue.