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, 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02170337

Enrollment

Registered

2014-06-23

Start date

2014-07-31

Completion date

2016-05-31

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Brief summary

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

Interventions

DRUGAMG 282

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

DRUGPlacebo

Contains no active drug

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	169 days	Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
Immunogenicity	169 days	Subject incidence of anti-AMG 282 antibodies

Secondary

Measure	Time frame	Description
Pharmacokinetic profile of AMG 282	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 \[Cmax\]).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026