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Safety Study of ALTB-268 in Healthy Volunteers

This study is testing a new monoclonal antibody called ALTB-268. It's designed to see how safe ALTB-268 is and how well healthy people tolerate it when given through an IV (intravenous) infusion. Researchers will also look at how the body processes ALTB-268. You might be able to join if you are a healthy non-smoker between 18 and 55 years old, with a specific body mass index and weight. The study aims to understand any side effects and how the body reacts to ALTB-268. The current recruitment status is unclear, and about 24 healthy participants are planned.

Study design
This is a Phase 1, randomized, double-blind study where participants will receive either ALTB-268 or a placebo (saline solution). Approximately 24 healthy participants will be involved.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, up to day 71 of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07350577

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

Active, Not Recruiting
PHASE1Ages 18–55InterventionalTreatment
AltruBio Inc.
~24 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:ALTB-268Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Adverse Events
Measured over Through study completion, up to day 71 of the study
+4 more outcomes measured

Conditions

Ulcerative Colitis (UC)

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Florida1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Adverse EventsThrough study completion, up to day 71 of the study

    \- Numbers of participants with adverse events (AEs): seriousness, severity, relationship to the investigational products, outcome, duration, and management

  • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Infusion Site AssessmentsThrough study completion, up to day 71 of the study

    \- Infusion site assessments, the extent of local reaction at the infusion site will be graded using the scores described below; a global severity rating for infusion site reactions will be included in the assessment of AEs. Infusion Site Reaction Score: None: No reaction; Mild: Tenderness with or without associated symptoms; Moderate: Pain; lipodystrophy; edema; phlebitis; Severe: Ulceration or necrosis; severe tissue damage; operative intervention indicated.

  • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - C-SSRSThrough study completion, up to day 71 of the study

    \- Columbia suicidality severity rating scale (C-SSRS) is a suicidal ideation and behavior rating scale to evaluate suicide risk.

  • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - PHQ-8Through study completion, up to day 71 of the study

    \- Patient Health Questionnaire-8 (PHQ-8) depression scale is used for depression screening and severity.

  • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Clinical Laboratory TestThrough study completion, up to day 71 of the study

    \- Clinical laboratory test results, including white blood cell, lymphocyte and neutrophail (cell counts/ul).