a study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of amg 592 in healthy participants

Conditions: Chronic Graft-versus-host Disease (cGVHD)

Summary: the primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of amg 592 in healthy participants.


Eligibility criteria:
inclusion criteria: * males must agree to practice an acceptable method of effective birth control while on study through 2 weeks after receiving the dose of study drug. * 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 hepatitis b surface antigen (hepbsag) (indicative of chronic hepatitis b) or detectable hepatitis c virus ribonucleic acid (rna) by polymerase chain reaction (pcr) (indicative of active hepatitis c - screening is generally done by hepatitis c antibody (hepcab), followed by hepatitis c virus rna by pcr if hepcab is positive). * 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.

Keywords: chronic graft-versus-host disease amg 592 inflammatory conditions