Evaluation of the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Intravenous ATYR1923 in Healthy Volunteers.

Exclusion Criteria49

• Exposure to any prescription medications (small molecules, biologics
• including vaccines) or, systemically administered over the counter drugs,
• dietary supplements or herbal remedies, within 30 days or 5 half-lives (if
• known), whichever is longer, prior to Day -1. An exception is made for
• hormonal contraceptives and a limited amount of paracetamol for the
• treatment of headache or any other pain.
• Any condition which (while not requiring regular use of medication) is likely
• to require intermittent (as required) therapeutic intervention (e.g., seizure
• disorder, seasonal allergies, asthma) at any point during the study.
• History of significant drug allergies or a history of anaphylactic reaction.
• History of any clinically significant condition (including and not limited to
• the gastrointestinal, renal, hepatic, cardiovascular, respiratory, or neurological
• systems) and/ or other major disease or malignancy, as determined by the
• Investigator.
• Major surgery within 3 months prior to Day -1 or anticipated surgery during
• the study.
• Any condition that necessitated hospitalization within the 3 months prior to
• Day -1 or is likely to require so during the study.
• Blood/plasma donation or blood loss greater than or equal to 470 ml within 3 months prior to Day -1.
• Participation in another clinical study of an investigational agent within
• months (small molecules) / 6 months (biologics) or 5 half-lives of the agent
• (if known), whichever is longer.
• History of, or positive results of screening for: hepatitis B (hepatitis B surface
• antigen [HBsAg]), hepatitis C (anti-hepatitis C virus [HCV] antibodies) or
• human immunodeficiency virus (HIV) (antibodies to HIV types 1 and 2).
• History of drug or alcohol abuse within 12 months prior to Day -1, or
• evidence of such abuse on laboratory assays at screening. Drug or alcohol
• abuse includes heavy smoking (> 1 pack per day), frequent use of recreational
• drug products, and an average intake of more than 24 units of alcohol per
• week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of
• wine or 35 mL of spirits).
• History of alcohol consumption in the 3 days prior to Day -1, or inability to
• abstain from alcohol consumption during the study.
• Clinically significant abnormalities in the screening physical examination,
• vital signs, electrocardiogram (ECG) or clinical laboratory tests, as
• determined by the Investigator. Repeat testing may be performed at the
• Investigator’s discretion.
• Jo-1 positivity during Screening or past history of Jo-1 positivity.
• Unable to refrain from strenuous activity for a period of 4 days before Day -1
• and for the duration of the study.
• Unlikely to comply with the clinical study protocol; e.g., uncooperative
• attitude, inability to return for follow-up visits, and improbability of
• completing the study.
• Any other condition, which in the opinion of the Investigator precludes the
• subject’s participation in the clinical study.
• Significant and/or acute illness within 5 days prior to (the first) drug
• administration that may impact safety assessments, in the opinion of the
• Investigator.
• An employee of the Contract Research Organization (CRO) or the Sponsor.