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

NCT02348879 | Completed Phase 1

• 1 other identifier: 20040195
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment emergent adverse events

  up to 112 days

• Incidence of abnormal clinically significant vital signs

  Vital signs to be assessed included temperature, respiratory rate, pulse rate and rhythm (regular/irregular), and blood pressure. Generally, abnormal vital signs were only reported as adverse events if they required treatment or were associated with an adverse event.

  up to 112 days

• Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

  Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.

  up to 112 days

• Incidence of abnormal clinically significant ECG results

  ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.

  up to 112 days

Secondary Outcomes (1)

• Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax

  up to 112 days

Study Arms (2)

AMG 403

EXPERIMENTAL

AMG 403 administered as subcutaneous and intravenous doses

Drug: AMG 403

Placebo

PLACEBO COMPARATOR

No active drug

Drug: Placebo

Interventions

AMG 403 DRUG

AMG 403 is for treatment of subjects with chronic pain

AMG 403

Placebo DRUG

contains no active drug

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Gow JM, Tsuji WH, Williams GJ, Mytych D, Sciberras D, Searle SL, Mant T, Gibbs JP. Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects. Arthritis Res Ther. 2015 Oct 8;17:282. doi: 10.1186/s13075-015-0797-9.

  PMID: 26449617 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Chronic Pain

Interventions

AMG 403

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 28, 2015
• Study Start: January 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: March 1, 2006
• Last Updated: January 30, 2015

Record last verified: 2015-01