NCT01928368

Brief Summary

The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy subjects and subjects with mild atopic asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1 asthma

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1 asthma

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

2.6 years

First QC Date

August 21, 2013

Last Update Submit

December 13, 2016

Conditions

Asthma

Keywords

Mild asthmaAtopic asthmaHealthy volunteersFirst-in-human

Outcome Measures

Primary Outcomes (5)

  • Incidence of treatment emergent adverse events

    Up to day 141

  • Incidence of abnormal clinically significant vital signs

    Up to day 141

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

    Up to day 141

  • Incidence of abnormal clinically significant ECG results

    Up to day 141

  • Incidence of anti-AMG 282 antibodies

    Up to 1 year

Secondary Outcomes (1)

  • Determination of various PK parameters including tmax, AUClast and Cmax

    Up to day 141

Other Outcomes (1)

  • Measurement of various pharmacodynamic biomarkers in subjects with mild atopic asthma

    Up to day 141

Study Arms (2)

Experimental Arm

ACTIVE COMPARATOR
Drug: AMG 282

Placebo Arm

PLACEBO COMPARATOR
Drug: AMG 282 Matching Placebo

Interventions

AMG 282DRUG

Single dose either subcutaneously or intravenously on day 1.

Experimental Arm
AMG 282 Matching PlaceboDRUG

Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.

Placebo Arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
  • Females must be of documented non-reproductive potential (ie, postmenopausal \[see definition below\]; OR history of hysterectomy; OR history of bilateral salpingectomy; OR history of bilateral oophorectomy).
  • Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (Subjects with mild atopic asthma only)
  • Documented history of mild, stable atopic asthma within 2 years of screening.
  • Has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
  • Pre-bronchodilator forced expiratory volume in 1 second (FEV1) \> 70% predicted at screening.

You may not qualify if:

  • (All subjects)
  • History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Principal Investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  • Subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (PPD) or QuantiFERON test at screening. Subjects with a documented negative PPD or QuantiFERON test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
  • Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP.
  • Other criteria may apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Cypress, California, 90630, United States

Location

Research Site

Aventura, Florida, 33180, United States

Location

Research Site

Lenexa, Kansas, 66219, United States

Location

Research Site

Raleigh, North Carolina, 27612, United States

Location

Research Site

Seattle, Washington, 98115, United States

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 23, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 14, 2016

Record last verified: 2016-12

Locations

US(5)