Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01164904

Enrollment

Registered

2010-07-19

Start date

2010-07-31

Completion date

2013-03-31

Last updated

2013-07-25

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

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Disease, Amgen

Brief summary

To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)

Interventions

DRUGAmg 181

Ten escalating dose levels of AMG 181 administered as single dose SC or IV, in healthy volunteers and SC subjects with mild-to-moderate ulcerative colitis.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy Volunteers * Healthy male or female subjects of non-reproductive potential between 18 to 45 year-of -age * Body Mass Index (BMI) between 18 and 34 kg/m2 * Normal physical and neurological examination, clinical laboratory values and ECG * Additional inclusion criteria apply Inclusion Criteria: Subjects with Mild to Moderate Ulcerative Colitis * Male or female subjects between 18 to 55 year-of -age * Body Mass Index (BMI) between 18 and 34 kg/m2 * Diagnosis of Ulcerative Colitis for at least 2 months * Active, mild to moderate disease as defined by an Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 9 (inclusive), with a minimum sigmoidoscopy score of 1 * Additional inclusion criteria apply

Exclusion criteria

Healthy Volunteers * History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion * History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years * Recent or on-going infection(s) * Underlying condition(s) that predisposes the subject to infections * Additional

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)	Through study completion

Secondary

Measure	Time frame
To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181	Through study completion
To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations	Through study completion

Countries

Australia, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026