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

• ClinicalTrials.gov Identifier: NCT02348879
• Recruitment Status: Completed
• First Posted: January 28, 2015
• Last Update Posted: January 30, 2015
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Drug: AMG 403; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Placebo Controlled, Randomized, Double-blind, Sequential, Rising, Single Dose Study to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous AMG 403 in Healthy Young and Older Adult Subjects
• Study Start Date: January 2005
• Actual Primary Completion Date: January 2006
• Actual Study Completion Date: March 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: AMG 403; AMG 403 administered as subcutaneous and intravenous doses	Drug: AMG 403; AMG 403 is for treatment of subjects with chronic pain
Placebo Comparator: Placebo; No active drug	Drug: Placebo; contains no active drug

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment emergent adverse events [ Time Frame: up to 112 days ]
2. Incidence of abnormal clinically significant vital signs [ Time Frame: up to 112 days ]
   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.
3. Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results [ Time Frame: up to 112 days ]
   Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.
4. Incidence of abnormal clinically significant ECG results [ Time Frame: up to 112 days ]
   ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.

Secondary Outcome Measures :

1. Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax [ Time Frame: up to 112 days ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT02348879
• Other Study ID Numbers: 20040195
• First Posted: January 28, 2015
• Last Update Posted: January 30, 2015
• Last Verified: January 2015

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations