A Phase 1 interventional study of ALTB-268 and Placebo in Ulcerative Colitis (UC), sponsored by AltruBio Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by AltruBio Inc. · Phase 1, Interventional, and Treatment
Among 615 studies in Colitis, Ulcerative with a site in United States — 116 open to participants now, 167 under way, 34 of them phase 3. Colitis, Ulcerative · United States.
Among the 615 studies in Colitis, Ulcerative with a site in United States, this one is the 379th largest by enrollment of the 499 interventional ones that give a count, is one of 38 that started in 2025, is one of 76 in phase 1, and was the 581st registered.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
Browse Colitis, Ulcerative studies →116 of the 615 studies in Colitis, Ulcerative with a site in United States are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Sites in United States
University of Minnesota · Sites in United States
Muhammad N Aslam, MD · Sites in United States
Vanda Pharmaceuticals · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 305 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 134 (44%) stop at 75 or younger; 71 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
615 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 87 · Phase 2 173 · Phase 3 132 · Phase 4 33
First in 1995; this study’s year is marked. 38 started in 2025.
This study's enrollment of 24 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 76 across the 499 interventional studies, 198 across the 113 observational. Of the 407 that completed or were terminated, 192 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
332 of 615 have an industry lead sponsor. The 10 most frequent:
AltruBio Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
AltruBio Inc. has 3 studies filed under Colitis, Ulcerative — fewer than ten, so there is no comparison to draw.
55 of the studies in Colitis, Ulcerative with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589986Phase 3Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | 2027-01-30 |
| NCT06260163Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | 2027-02-10 |
| NCT04624230Phase 3PfizerEvaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | 2027-03-17 |
| NCT03006068Phase 3AbbVieA Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | 2027-07 |
| NCT06880744Phase 3AbbVieA Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab | 2027-08 |
Among the 615 studies in Colitis, Ulcerative with a site in United States, from their registry updates:
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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.
This is a Phase I, randomized, double-blind, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenously administered ALTB-268 in healthy participants. Approximately 24 healthy participants will be recruited.
The primary objective is to evalute the safety and tolerability of intravenous infusion of SAD in healthy participants. The secondary objectives are (1) to characterize the PK profile of ALTB-268 in plasma following single IV doses in healthy participants, and (2) to assess the PD of ALTB-268 following single IV doses in healthy participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy as defined by:
Female participants of non- must be:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenously administered
Biological: ALTB-268
Intravenously Administered
Other: Placebo
monoclonal antibody
Saline solution
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 AUC
* AUC0-t, area under the concentration-time curve from time 0 to t hours * AUC0-inf, area under the concentration-time curve from time 0 to infinity
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Cmax
Mmaximum concentration (Cmax)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Tmax
Time to reach Cmax (Tmax)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 T½
Terminal half-life (T½)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 CL
Total body clearance (CL)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Vz
Volume of distribution (Vz)
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Vss
Steady-state volume of distribution (Vss)
Time frame: Through study completion, up to day 71 of the study
Pharmacodynamics (PD) of ALTB-268 following single IV doses in healthy participants.
Levels of free soluble P-selectin glycoprotein ligand-1 (sPSGL-1) in plasma.
Time frame: Through study completion, up to day 71 of the study
Immunogenicity of ALTB-268 in plasma following single IV doses in healthy participants
Incidence and level of anti-drug antibodies (ADAs).
Time frame: Through study completion, up to day 71 of the study
Ran from Nov 2025 to primary completion in Apr 2026, 4 months.
Of 57 industry-sponsored phase 1 interventional studies under Colitis, Ulcerative, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 17. This study's 4 months is below that.
Counting every sponsor, half of 83 studies reached it within 13 months; a quarter within 8 and three quarters within 26.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Sep 2026 → Apr 2026 and completion Sep 2026 → Apr 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ALTB-268
AltruBio Inc.