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

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT07350577

Run by

AltruBio Inc.

People needed

24

Starts

2025-11-17

Expected to finish

2026-09-28

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body mass index (BMI) >18.5 and <32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic diseases.
• Female participants of non-childbearing potential must be:
• post-menopausal (spontaneous amenorrhea for at least 12 consecutive months prior to dosing) with confirmation by documented follicle- stimulating hormone (FSH) levels ≥40 mIU/mL; or
• surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal ligation) at least 3 months prior to dosing.
• 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.

You may not qualify if…

• Any clinically significant abnormal finding at physical examination at screening and/or Day -1.
• Clinically significant abnormal laboratory test results at screening and/or Day -1; or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.
• 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.
• Any history of clinical depression.
• C-SSRS score at Day -1 (baseline) above Type 1 ideation.
• PHQ-8 total score ≥5 at screening and/or Day -1 (baseline).

Where it is running

• Syneos Health Clinical Research Services, LLC — Miami, Florida, United States

Full record on ClinicalTrials.gov

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