RecruitingPhase 1NCT07350577

Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety Tolerability, Pharmacokinetics, and Pharmacosymics of Single Ascending Doses of Intravenously Administerted ALTB-268 in Healthy Participants


Sponsor

AltruBio Inc.

Enrollment

24 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of intravenously administrated ALTB-268 in healthy participants.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human safety study of a new investigational drug called ALTB-268, given by IV infusion, in healthy adults. The study is testing single doses to see how the drug behaves in the body and whether it causes any side effects before it can be tested in patients with a specific disease. **You may be eligible if...** - You are 18–55 years old - You are a healthy non-smoker (no tobacco or nicotine use in the past 3 months) - You have a BMI between 18.5 and 32 and weigh at least 50 kg (men) or 45 kg (women) - You have no significant medical, mental health, or surgical history - For women: you are post-menopausal or have had surgical sterilization **You may NOT be eligible if...** - You have any clinically significant abnormal findings on physical exam or lab tests - You test positive for hepatitis B, hepatitis C, HIV, or tuberculosis - You have any history of suicidal thoughts, depression, or score above a mild level on mood questionnaires - You have had any serious mental health history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALALTB-268

monoclonal antibody

OTHERPlacebo

Saline solution


Locations(1)

Syneos Health Clinical Research Services, LLC

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07350577


Related Trials