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Completed

NCT Number: NCT02170337

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps

A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Santa Monica, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy Volunteers:

Inclusion criteria

  • Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive

Exclusion criteria

  • subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.

Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP):

Inclusion criteria

  • diagnosis of CRSwNP (inflammation of the nose and paranasal sinuses characterized in adults by 2 or more symptoms, 1 of which should be either nasal blockage or nasal discharge and/or facial pain and/or reduced smell for greater than 12 weeks)
  • bilateral nasal polyps of grade 3 or 4

Exclusion criteria

  • Forced Expiratory Volume (FEV1) </= 70%
  • Asthma exacerbation requiring systemic corticosteroid treatment or hospitalization for > 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.

Treatment and study plan

AMG 282

Drug

AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps

Placebo

Drug

Contains no active drug

Primary outcomes

  1. Safety and tolerability

    Time frame: 169 days

    Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)

  2. Immunogenicity

    Time frame: 169 days

    Subject incidence of anti-AMG 282 antibodies

Secondary outcomes

  1. Pharmacokinetic profile of AMG 282

    Time frame: 169 days

    Serum concentrations and derived PK parameters (eg, time to maximum concentration [tmax], area under the concentration-time curve over the dosing interval τ [AUCτ] after the first and last dose, and maximum observed concentration [Cmax]).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2014
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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