Safety Study of AMG 157 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00972179
First received: September 3, 2009
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

This study will follow a randomized, multiple-dose, double-blind, placebo-controlled, sequential dose-escalation study design. This healthy volunteer study will consist of five subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort will enroll 8 subjects, randomized such that 6 subjects will receive AMG 157 and 2 will receive placebo (3:1 ratio). The doses of AMG 157 planned to be evaluated include 35 mg (SC every 28 days, Cohort 1), 105 mg (SC every 28 days, Cohort 2), 210 mg (SC every 28 days, Cohort 3), 210 mg (SC every 14 days, Cohort 4), 210 mg (SC every 7 days, Cohort 5) and 700 mg (IV every 28 days, Cohort 6).


Condition Intervention Phase
Healthy Volunteers
Drug: AMG 157 Placebo
Drug: AMG 157
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 157 in Healthy Subjects

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety evaluations: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations, laboratory safety tests, ECGs, and the development of anti-AMG 157 antibodies [ Time Frame: 169 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum PK parameters [ Time Frame: 169 days ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 157
Six subjects in each cohort (cohorts 1 to 6) will receive AMG 157 for a total of 36 subjects.
Drug: AMG 157
A total of 36 subjects will be receiving multiple doses of AMG 157 (dose escalating by cohort). Each subject enrolled in cohorts 1-3 will receive three SC doses; each subject enrolled in cohort 4 will receive six SC doses; each subject enrolled in cohort 5 will receive 12 SC doses; and each subject enrolled in cohort 6 will receive three IV doses throughout the study period of 169 days.
Placebo Comparator: AMG 157 Placebo
Two subjects in each cohort (cohorts 1 to 6) will receive placebo, for a total of 12 subjects.
Drug: AMG 157 Placebo
A total of 12 subjects will be receiving multiple doses of AMG 157 placebo. Each subject enrolled in cohorts 1-3 will receive three SC doses; each subject enrolled in cohort 4 will receive six SC doses; each subject enrolled in cohort 5 will receive 12 SC doses; and each subject enrolled in cohort 6 will receive three IV doses throughout the study period of 169 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must sign an Institutional Review Board (IRB) approved informed consent form before any study-specific procedures;
  • Healthy subject, aged between 18 and 45 years, inclusive;
  • Female subject must be of non-reproductive potential (ie, postmenopausal by history - no menses for ≥ 1 year and by FSH [using local reference ranges]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy);
  • Male subjects with female partner of childbearing potential who agrees to inform their female partner of their participation in this clinical study and use highly effective methods of birth control during the study. (Highly effective methods of birth control may include abstinence, vasectomy, or a condom with spermicide in combination with either hormonal birth control, IUD or barrier methods used by the woman.);
  • Male subject who agrees to use birth control for five months after last dose of study medication, male subject who agrees not to donate sperm during the study and for five months after last dose of study medication;
  • Healthy subject with a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening;
  • Subject must have normal or clinically acceptable physical examination and electrocardiogram (ECG) results (12-lead reporting RR, PR, QRS, QT and QTcF) prior to Day 1 based on the opinion of the investigator;
  • Subject must have normal or clinically acceptable clinical laboratory tests at screening as determined by Amgen and the investigator;
  • Subject must have adequate renal function (defined as CrCl > 80 mL/min using the Cockcroft Gault equation).

Exclusion Criteria:

  • Subject who has history or evidence of a clinically significant disorder, condition or disease (including but not limited to cardiopulmonary, oncologic, immunologic, autoimmune, collagen vascular, renal, metabolic, hematologic or psychiatric), that, in the opinion of the Investigator in consultation with the Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
  • Subject who has evidence of any active or suspected bacterial, viral, fungal or parasitic infections within the past 30 days prior to randomization (eg, common cold, viral syndrome, flu-like symptoms). Subject who, in the opinion of the investigator, has a high risk of parasitic disease is also excluded;
  • Subject who has known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or recent (within six months from randomization) exposure to an individual with active tuberculosis;
  • Subject who has history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within five years before randomization of the study;
  • Subject who has known type I/II diabetes;
  • Subject who uses nonprescription drugs within 14 days prior to randomization and for the entire duration of the study. All herbal supplements, vitamins, and nutritional supplements taken within the last 30 days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed and approved by the PI and Amgen Medical Monitor;
  • Subject who has used any systemic cytotoxic or systemic immunosuppressive medications (other than corticosteroids) within 6 months prior to randomization and for the entire duration of the study; subject who has used any corticosteroid, topical cytotoxic or topical immunosuppressive medications within 30 days or five half-lives (whichever is longer) prior to randomization and for the entire duration of the study;
  • Subject who has previously received any other therapeutic monoclonal antibody;
  • Subject who has previously received any investigational drug (or is currently using an investigational device) within 30 days or five half-lives (whichever is longer) prior to randomization;
  • Subject who has tested positive for drugs and/or alcohol use at screening or before randomization, subject who has consumed alcohol within 48 hours prior to any study visit including screening, and subject with alcohol intake of > 2 drinks/day on average during the study (one drink being equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine or 1.5 ounces of 80 proof distilled spirits);
  • Female subject who is pregnant or lactating; female subject who is of child-bearing potential;
  • Subject who has donated blood (including blood products) or experienced loss of blood ≥ 500 mL within two months of study screening;
  • Subject who is positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
  • Subject who has regularly used nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) during six months before randomization and during the study;
  • Subject who has any other condition that might reduce the chance of obtaining data (eg, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972179

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00972179     History of Changes
Other Study ID Numbers: 20080390
Study First Received: September 3, 2009
Last Updated: August 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
healthy volunteers

ClinicalTrials.gov processed this record on September 18, 2014