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Safety Study of AMG 157 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00972179
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : August 26, 2011
Sponsor:
Information provided by:
Amgen

Tracking Information
First Submitted Date  ICMJE September 3, 2009
First Posted Date  ICMJE September 4, 2009
Last Update Posted Date August 26, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Serum PK parameters [ Time Frame: 169 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of AMG 157 in Healthy Subjects
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 157 in Healthy Subjects
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: AMG 157
    Six subjects in each cohort (cohorts 1 to 6) will receive AMG 157 for a total of 36 subjects.
    Intervention: Drug: AMG 157
  • Placebo Comparator: AMG 157 Placebo
    Two subjects in each cohort (cohorts 1 to 6) will receive placebo, for a total of 12 subjects.
    Intervention: Drug: AMG 157 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2011)
49
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2009)
24
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00972179
Other Study ID Numbers  ICMJE 20080390
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP