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

Amgen

Status and phase: Completed; Phase 1

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: AMG 282; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170337

20110236

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

41 participants in 2 patient groups, including a placebo group

AMG 282

Experimental group

Description:

AMG 282 administered as subcutaneous and intravenous doses.

Treatment:

Drug: AMG 282

Placebo

Placebo Comparator group

Description:

No active drug

Treatment:

Drug: Placebo