CompletedInterventionalPhase 1Updated May 14, 2024
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects | NCT01695876 | Trialant
CompletedInterventionalPhase 1Updated Mar 4, 2015
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
ClinicalTrials.gov ID
NCT01695876
Lead Sponsor
AmgenINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
58Actual
Last Update Posted
Mar 4, 2015Estimated
Start Date
Oct 2012
Primary Completion Date
Sep 2014Actual
Completion Date
Oct 2014Actual
Brief Summary
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
Inflammatory Disease
AMG 357
Placebo
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility 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.