Clinical trial NCT01290042: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.
Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Crohn's Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-02-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 34 kg/m2
* Normal physical and neurological examination, clinical laboratory values and ECG
* Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subjects with ulcerative colitis)
* Crohn's Disease Activity Index (CDAI) score of \>150 and \< 450 at screening (for subjects with Crohn's disease)
* Additional inclusion criteria apply

Exclusion Criteria:

* 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
* Underlying condition(s) that predisposes the subject to infections
* Disease limited to the rectum, i.e. within 10 cm of the anal verge (for subjects with ulcerative colitis)
* Evidence of severe disease (as evidenced by an Hb concentration less or equal to 10g/dL; toxic megacolon, or an UCDAI score greater than 10) (for subjects with ulcerative colitis)
* Subject has short bowel syndrome (for subjects with Crohn's disease)
* Presence of an ostomy (for subjects with Crohn's disease)
* Presence of a fistula (for subjects with Crohn's disease)
* Additional exclusion criteria apply

Primary outcomes:
measure: To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
timeFrame: 40 Weeks
Secondary outcomes:
measure: To measure the area under the plasma concentration curve versus time of drug AMG 181.
timeFrame: 29 Weeks
measure: To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181.
timeFrame: 29 Weeks
measure: To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181.
timeFrame: 29 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Miami
country: United States
facility: Research Site
state: Florida
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
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: