A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants
NCT ID: NCT05873907
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2015-10-19
2017-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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AMG 592: Dose 1
Administered as a single dose subcutaneous (SC) injection.
AMG 592
Administered as SC injection
AMG 592: Dose 2
Administered as a single dose SC injection.
AMG 592
Administered as SC injection
AMG 592: Dose 3
Administered as a single dose SC injection.
AMG 592
Administered as SC injection
AMG 592: Dose 4
Administered as a single dose SC injection.
AMG 592
Administered as SC injection
AMG 592: Dose 5
Administered as a single dose SC injection.
AMG 592
Administered as SC injection
AMG 592: Dose 6
Administered as a single dose SC injection.
AMG 592
Administered as SC injection
AMG 592: Dose 7
Administered as a single dose SC injection.
AMG 592
Administered as SC injection
AMG 592: Dose 8
Administered as a single dose SC injection.
AMG 592
Administered as SC injection
Placebo
Administered as SC injection.
Placebo
Administered as SC injection
Interventions
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AMG 592
Administered as SC injection
Placebo
Administered as SC injection
Eligibility Criteria
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Inclusion Criteria
* Males must be willing to abstain from sperm donation while on study through 2 weeks after receiving the (last \[multiple dose studies\]) dose of study drug.
* Male and female subjects ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m\^2 at the time of screening.
* Females must be of non-reproductive potential (ie, postmenopausal - age ≥ 55 years with cessation of menses for 12 months or more, or according to the definition of "postmenopausal range" for the laboratory involved OR history of hysterectomy; OR history of bilateral oophorectomy).
Exclusion Criteria
* Positive results for Human Immunodeficiency Virus (HIV).
* Participant has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or participant has a positive purified protein derivative (PPD) or QuantiFERON or T-Spot test at Screening. Participants with a documented negative PPD or QuantiFERON or T-Spot 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.
* Currently receiving treatment in another investigational device or drug study, or less than 30 days or less than 5 half-lives, whichever is longer, since ending treatment on another investigational device or drug study.
* Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
* Any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1.
* Females who are lactating/breastfeeding or who plan to breastfeed while on study through 2 weeks after receiving the dose of study drug.
* Female participants with a positive pregnancy test.
* Males with partners who are pregnant or planning to become pregnant while the participant is on study through 2 weeks after receiving the dose of study drug.
* Has any significant abnormality during the screening physical examination, electrocardiogram (ECG), or laboratory evaluation that in the opinion of the Investigator, in consultation with the Amgen Medical Monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including Screening).
* Is a current smoker, has 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 from Screening, and cumulative smoking history is ≥ 10 pack years.
* Unwilling or unable to refrain from strenuous exercise (eg, heavy lifting, weight training, and aerobics) for 72 hours prior to each visit that includes blood collection.
* Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP.
* Participants with a known history of autoimmune disease.
18 Years
55 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Aventura, Florida, United States
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20140324
Identifier Type: -
Identifier Source: org_study_id
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