ALTB-268 for Ulcerative Colitis

Overseen By Simona Reed, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AltruBio Inc.

Disqualifiers: Hepatitis, HIV, Tuberculosis, Depression, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and tolerability of a new treatment, ALTB-268, when administered intravenously to healthy individuals. It is not yet intended for directly treating ulcerative colitis; instead, it serves as an initial step to assess how the body processes the treatment. Participants will receive either ALTB-268 or a placebo (a harmless saline solution). This trial suits healthy non-smokers who have not experienced any major illnesses or surgeries in the past month. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment functions in people.

Is there any evidence suggesting that ALTB-268 is likely to be safe for humans?

In a previous study, researchers found that ALTB-268 did not cause any serious side effects in healthy volunteers. They tested different doses of the treatment and found it was well-tolerated by all participants. No serious health problems emerged. This suggests that ALTB-268 is generally safe for humans based on the available evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ulcerative colitis, which often include anti-inflammatory drugs like mesalamine or immunosuppressants such as azathioprine, ALTB-268 is unique because it is a biological treatment that is administered intravenously. This method allows for potentially faster delivery and absorption into the body, which could lead to quicker relief of symptoms. Researchers are particularly excited about ALTB-268 because it targets specific pathways in the immune system, which may offer more precise control over inflammation compared to broader immunosuppressive therapies. This targeted approach could mean fewer side effects and a more effective treatment for those with ulcerative colitis.

What evidence suggests that ALTB-268 might be an effective treatment for ulcerative colitis?

Research has shown that ALTB-268, which participants in this trial may receive, holds promise for treating inflammatory conditions like ulcerative colitis. In early studies with mice, ALTB-268 significantly improved survival rates and reduced disease severity. It targets PSGL-1 to help control inflammation. This treatment is stronger than its predecessor, ALTB-168, suggesting it might more effectively reduce inflammation. Early results also indicate that ALTB-268 exhibits strong biological activity, a positive sign for its potential effectiveness in humans. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can safely receive intravenous treatments. Specific eligibility criteria are not provided, but typically participants should have no significant medical conditions and be willing to follow the study procedures.

Inclusion Criteria

I am 18-55 years old, a non-smoker, with a healthy weight and BMI.

I am a woman who cannot have children because I am post-menopausal or have had surgery to prevent pregnancy.

Able to understand the study procedures, agree to comply with all study visits, procedures, and restrictions, agree to comply with the prescribed dosage regimens and communicate to study personnel about AEs and concomitant medication use, and provide signed informed consent to participate in the study

Exclusion Criteria

Any clinically significant abnormal finding at physical examination at screening and/or Day -1

I do not have significant abnormal lab results or positive tests for HBsAg, HCV, HIV, or TB.

Any history of suicidal ideation as evidenced by answering 'yes' to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at screening, or any history of suicide attempts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of intravenously administered ALTB-268 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics of ALTB-268

10 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ALTB-268

Trial Overview

The trial is testing ALTB-268, a new drug given through an IV. It's being compared to a placebo (a treatment with no active drug). The goal is to see how safe it is and how the body reacts to different doses in people who don't have Ulcerative Colitis.

How Is the Trial Designed?

Group I: Biological: ALTB-268 Experimental Treatment 1 Intervention

Intravenously administered

Group II: Placebo (Saline solution) Placebo Group 1 Intervention

Intravenously Administered

Who Is Running the Clinical Trial?

AltruBio Inc.

Lead Sponsor

Trials

4

Recruited

150+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06109441

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to ...

ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with ...

2.

biospace.com

biospace.com/press-releases/altrubio-presents-new-preclinical-data-at-focis-2025-demonstrating-altb-268s-efficacy-in-t-cell-mediated-inflammatory-models

AltruBio Presents New Preclinical Data at FOCIS 2025 ...

In a human-mouse xenogeneic GvHD (xGvHD) model, ALTB-268 significantly improved survival, reduced disease severity score and body weight loss, ...

3.

authorea.com

authorea.com/users/901210/articles/1276444-a-first-in-human-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-altb-268-a-novel-psgl-1-agonistic-antibody

A FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY ...

ALTB-268 is a second-generation PSGL-1 agonistic antibody proposed for the treatment of UC that demonstrates increased potency compared to ...

4.

altrubio.com

altrubio.com/altrubio/en/news/akjrkgjllyex

News & Events

ALTB-268 demonstrated its anti-inflammatory effect in an acute colitis hPSGL-1 mouse model. The data confirmed that ALTB-268 acts as an immune ...

5.

firstwordpharma.com

firstwordpharma.com/story/5766294

AltruBio Announces Positive Topline Data from Phase 1 ...

ALTB-268 demonstrated substantially greater biological activity than first ICE molecule, ALTB-168, enabling subcutaneous administration.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07350577

Evaluate the Safety, Tolerability, PK and PD of SAD ...

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

7.

patientworthy.com

patientworthy.com/2023/08/08/positive-ulcerative-colitis-topline-data-altb-268/

Positive Topline Data Available on ALTB-268 for Ulcerative ...

Positive Topline Data Available on ALTB-268 for Ulcerative Colitis ... Within the trial, researchers evaluated the therapy's safety ...