A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)

An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02749630

Enrollment

Registered

2016-04-25

Start date

2016-04-11

Completion date

2020-02-19

Last updated

2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis, Crohn's Disease

Brief summary

This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.

Interventions

DRUGPlacebo

Matching placebo to UTTR1147A administered intravenously

DRUGUTTR1147A

Escalating doses of intravenously administered UTTR1147A

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

General inclusion criteria: * No history of malignancy * Documentation of age-appropriate cancer screening based on local/country-specific guidelines * For women of childbearing potential: agreement to remain abstinent or use contraceptive methods * For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm For HVs Only: * Age 18 - 50 * Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2), inclusive * In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs, and clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor For Participants with UC or CD: * Age 18 - 80 * Eligible to receive biologic therapy * Disease duration of \>/= 12 weeks * Diagnosis of moderate to severe UC or CD

Exclusion criteria

General

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Adverse Events	Up to Day 134

Secondary

Measure	Time frame
Minimum (Trough) Serum Concentrations (Ctrough) of UTTR1147A Prior to the Second and Last Dose	Up to Day 134
Total Serum Clearance (CL) of UTTR1147A	Up to Day 134
Volume of Distribution (V) of UTTR1147A	Up to Day 134
Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose	Up to Day 134
Elimination Half-Life (t1/2) of UTTR1147A	Up to Day 134
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum	Up to Day 134
Area Under the Concentration vs. Time Curve (AUC) Within a Dose Interval (AUCtau) After the Final Dose of UTTR1147A	Up to Day 134

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026