Ulcerative Colitis (UC)Phase 1NCT07350577
Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants
A Phase 1 study testing ALTB-268 in people with Ulcerative Colitis (UC), run by AltruBio Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- ALTB-268
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 6 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Syneos Health Clinical Research Services, LLC
Miami, Florida, 33136
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety Tolerability, Pharmacokinetics, and Pharmacosymics of Single Ascending Doses of Intravenously Administerted ALTB-268 in Healthy Participants
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.
Read the detailed description
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.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- ALTB-268, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTB-268Biological
monoclonal antibody
PlaceboOther
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| Biological: ALTB-268 | Experimental | Intravenously administered Receives: Biological: ALTB-268 |
| Placebo (Saline solution) | Placebo comparator | Intravenously Administered Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Through study completion, up to day 71 of the study
Secondary outcomes (9)
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
Measured: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Cmax
Mmaximum concentration (Cmax)
Measured: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Tmax
Time to reach Cmax (Tmax)
Measured: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 T½
Terminal half-life (T½)
Measured: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 CL
Total body clearance (CL)
Measured: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Vz
Volume of distribution (Vz)
Measured: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Vss
Steady-state volume of distribution (Vss)
Measured: 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.
Measured: 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).
Measured: Through study completion, up to day 71 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start17 Nov 2025
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AltruBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350577
- Sponsor's protocol ID
- ALTB-268-102
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety Tolerability, Pharmacokinetics, and Pharmacosymics of Single Ascending Doses of Intravenously Administerted ALTB-268 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07350577
- Acronym / sponsor ID
- ALTB-268-102
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AltruBio Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological: ALTB-268 | Experimental | Biological: ALTB-268Intravenously administered |
| Placebo (Saline solution) | Placebo comparator | Other: PlaceboIntravenously Administered |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- Female participants of non-childbearing potential must be:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALTB-268monoclonal antibody | Biological | Biological: ALTB-268 |
| PlaceboSaline solution | Other | Placebo (Saline solution) |
Primary outcome
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Adverse Events
Time frame: Through 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 Assessments
Time frame: Through 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-SSRS
Time frame: Through 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-8
Time frame: Through 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 Test
Time frame: Through study completion, up to day 71 of the study
- Clinical laboratory test results, including white blood cell, lymphocyte and neutrophail (cell counts/ul).
9 secondary outcomes
Pharmacokinetic (PK) of ALTB-268 AUC
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Cmax
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Tmax
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 T½
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 CL
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 Vz
Time frame: Through study completion, up to day 71 of the study
Pharmacokinetic (PK) of ALTB-268 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.
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
Time frame: Through study completion, up to day 71 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALTB-268 in people with Ulcerative Colitis (UC), run by AltruBio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Adverse Events (time frame: Through study completion, up to day 71 of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.