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

NCT07350577 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: ALTB-268-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (5)

• To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Adverse Events

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

  Through study completion, up to day 71 of the study

• To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Infusion Site Assessments

  \- 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.

  Through study completion, up to day 71 of the study

• To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - C-SSRS

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

  Through study completion, up to day 71 of the study

• To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - PHQ-8

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

  Through study completion, up to day 71 of the study

• To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Clinical Laboratory Test

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

  Through study completion, up to day 71 of the study

Secondary Outcomes (9)

• Pharmacokinetic (PK) of ALTB-268 AUC

  Through study completion, up to day 71 of the study

• Pharmacokinetic (PK) of ALTB-268 Cmax

  Through study completion, up to day 71 of the study

• Pharmacokinetic (PK) of ALTB-268 Tmax

  Through study completion, up to day 71 of the study

• Pharmacokinetic (PK) of ALTB-268 T½

  Through study completion, up to day 71 of the study

• Pharmacokinetic (PK) of ALTB-268 CL

  Through study completion, up to day 71 of the study

Study Arms (2)

Biological: ALTB-268

EXPERIMENTAL

Intravenously administered

Biological: ALTB-268

Placebo (Saline solution)

PLACEBO COMPARATOR

Intravenously Administered

Other: Placebo

Interventions

ALTB-268 BIOLOGICAL

monoclonal antibody

Biological: ALTB-268

Placebo OTHER

Saline solution

Placebo (Saline solution)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• AltruBio Inc.: lead

Study Sites (1)

Syneos Health Clinical Research Services, LLC

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 20, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)