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Study Complete
Sponsor ID
20110246

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), food effect of AMG 357 in Healthy Subjects

Sponsor ID
20110246
Clinicaltrials.gov ID
NCT01695876
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects

Additional Study Details

Phase
Phase 1
Product
AMG 357
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
58
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety and Tolerability

Timeframe: up to 35 days

Secondary Outcome Measures

Pharmacodynamics

Timeframe: up to 35 days

Effect of Food on AMG 357

Timeframe: up to 11 days

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Christchurch, New Zealand
Status
Not yet recruiting
Location
Research Site
Christchurch, New Zealand, 8011
Status
Recruiting
Location
Research Site
Grafton, Auckland, New Zealand, 1010
Status
Recruiting
Study Info
Age
25 - 55 Years
Condition
  • Inflammation
    • Sex
    All
    Trial Dates
    Oct 2012 - Sep 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Healthy Adult subjects between 25 and 55 years old - Body mass index (BMI) between 18 and 32 kg/m2 - Normal or clinically acceptable physical examination, clinical laboratory values, and ECG - Additional inclusion criteria apply
    Exclusion Criteria:
    - Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety. - Additional exclusion criteria apply