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Monoclonal Antibodies

ALIA-1758 Safety Study in Healthy Participants

Phase 1
Recruiting
Research Sponsored by Aliada Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a body weight of at least 50.0 kg for men and 45.0 kg for women and a Body Mass Index (BMI) within the range of 17.5-32.0 kg/m2 (inclusive) at Screening
Be between 18 and 65 years old
Must not have
Clinically significant abnormality on physical examination, ECG, or laboratory evaluations at Screening or between Screening and (first) dose administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-85 days after dosing
Awards & highlights

Summary

"This trial is the first time ALIA-1758 will be tested in humans. It will involve healthy male and female participants who will receive either the study drug or a placebo. The main goal is

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is an early-stage trial for ALIA-1758, potential side effects are being investigated but may include typical reactions to injections like pain at injection site, fever, fatigue, headache or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 17.5 and 32.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no significant health issues found in recent tests or exams.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-85 days after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-85 days after dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: AUC
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Bioavailability
Pharmacokinetic parameters of ALIA-1758 in healthy subjects: Clearance
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Single Ascending Dose (SAD) cohorts
Group II: PlaceboPlacebo Group1 Intervention
Single Ascending Dose (SAD) cohorts

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Aliada TherapeuticsLead Sponsor
J. Michael Ryan, M.D.Study DirectorAliada Therapeutics
~22 spots leftby Jan 2025
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