Clinical trial NCT01164904: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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 exclusion criteria apply

Exclusion criteria: Subjects with Mild to Moderate Ulcerative Colitis

* Disease limited to the rectum, i.e. within 20 cm of the anal verge
* Any prior gastrointestinal surgery
* Evidence of severe disease (as evidenced by an Hb concentration \<11g/dL; toxic megacolon, or an UCDAI score≥10)
* Immunosuppressive therapy with either azathioprine, methotrexate, or mercaptopurine, within the past 3 months
* Prior exposure to a biologic agent or cyclosporine A
* Use of antibiotics within the past 2 weeks of screening and during screening period
* Use of topical (e.g. suppository or enema) mesalamine or steroids within two weeks prior to day 1
* Additional exclusion criteria apply

Primary outcomes:
measure: 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)
timeFrame: Through study completion
Secondary outcomes:
measure: To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181
timeFrame: Through study completion
measure: To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations
timeFrame: Through study completion
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Plymouth
country: United States
facility: Research Site
state: Minnesota
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Prahran
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Auckland
country: New Zealand
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: