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

Amgen

Status and phase: Completed; Phase 1

Conditions: Inflammatory Disease

Treatments: Drug: Placebo; Drug: AMG 357

Study type: Interventional

Funder types: Industry

Identifiers

NCT01695876

Inflammation (Other Identifier)

20110246

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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58 participants in 2 patient groups, including a placebo group

AMG 357

Experimental group

Description:

AMG 357 is a small molecule for treatment of inflammatory disease

Treatment:

Drug: AMG 357

Placebo

Placebo Comparator group

Description:

Matching placebo to AMG 357 containing no active drug

Treatment:

Drug: Placebo