A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject

Amgen

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Drug: Placebo; Drug: AMG 403

Study type: Interventional

Funder types: Industry

Identifiers

NCT02348879

20040195

Details and patient eligibility

About

This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.

Enrollment: 51 patients

Sex

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women of non-child bearing potential,
• Between the ages of 18 and 55 inclusive,
• Body mass index from 18 to 33 kg/m2,
• Skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct.

Exclusion criteria

• Prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia,
• Evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system,
• History of Raynaud's phenomenon; Know allergy or intolerance to capsaicin or hot peppers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

AMG 403

Experimental group

Description:

AMG 403 administered as subcutaneous and intravenous doses

Treatment:

Drug: AMG 403

Placebo

Placebo Comparator group

Description:

No active drug

Treatment:

Drug: Placebo