AsthmaPhase 1NCT01928368
A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.
A Phase 1 study testing AMG 282 in people with Asthma, run by Amgen at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- AMG 282
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2013to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Aventura, Florida, 33180
Research Site
Cypress, California, 90630
Research Site
Lenexa, Kansas, 66219
Research Site
Raleigh, North Carolina, 27612
Research Site
Seattle, Washington, 98115
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Mild Atopic Asthma
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.
Read the detailed description
A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.
- Conditions
- Asthma
- Being tested
- AMG 282, AMG 282 Matching Placebo
- Keywords
- Mild asthma, Atopic asthma, Healthy volunteers, First-in-human
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 282Drug
Single dose either subcutaneously or intravenously on day 1.
AMG 282 Matching PlaceboDrug
Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Active comparator | Not described Receives: Drug: AMG 282 |
| Placebo Arm | Placebo comparator | Not described Receives: Drug: AMG 282 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Measured: Up to day 141
Incidence of abnormal clinically significant vital signs
Measured: Up to day 141
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Measured: Up to day 141
Incidence of abnormal clinically significant ECG results
Measured: Up to day 141
Incidence of anti-AMG 282 antibodies
Measured: Up to 1 year
Secondary outcomes (1)
Determination of various PK parameters including tmax, AUClast and Cmax
Measured: Up to day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928368
- Sponsor's protocol ID
- 20110235
- Status last verified
- Dec 2016
- First submitted
- 21 Aug 2013
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang W, Cheung D, Fong A, Brooks L, Grimbaldeston MA, Arjomandi A, Yang X, Dash A, Wong H, Parnes JR, Mohan D. Safety, Pharmacokinetics, and Immunogenicity of Astegolimab, an Anti-ST2 Monoclonal Antibody, in Randomized, Phase I Clinical Studies. Clin Transl Sci. 2025 Oct;18(10):e70338. doi: 10.1111/cts.70338.
PubMed 41036707
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Mild Atopic Asthma
- ClinicalTrials.gov ID
- NCT01928368
- Acronym / sponsor ID
- 20110235
- Conditions
- Asthma
- Keywords
- Mild asthma, Atopic asthma, Healthy volunteers, First-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Active comparator | Drug: AMG 282 |
| Placebo Arm | Placebo comparator | Drug: AMG 282 Matching Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 282Single dose either subcutaneously or intravenously on day 1. | Drug | Experimental Arm |
| AMG 282 Matching PlaceboSingle dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1. | Drug | Placebo Arm |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Up to day 141
Incidence of abnormal clinically significant vital signs
Time frame: Up to day 141
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Time frame: Up to day 141
Incidence of abnormal clinically significant ECG results
Time frame: Up to day 141
Incidence of anti-AMG 282 antibodies
Time frame: Up to 1 year
1 secondary outcome
Determination of various PK parameters including tmax, AUClast and Cmax
Time frame: Up to day 141
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Derived from this study: PubMed 41036707Zhang W, Cheung D, Fong A, Brooks L, Grimbaldeston MA, Arjomandi A, Yang X, Dash A, Wong H, Parnes JR, Mohan D. Safety, Pharmacokinetics, and Immunogenicity of Astegolimab, an Anti-ST2 Monoclonal Antibody, in Randomized, Phase I Clinical Studies. Clin Transl Sci. 2025 Oct;18(10):e70338. doi: 10.1111/cts.70338.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 282 in people with Asthma, run by Amgen at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (time frame: Up to day 141). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.