A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NJA-730 in Healthy Volunteers

Exclusion Criteria25

• A subject will be ineligible for study participation if he meets any of the following criteria:
• The subject has a history or presence of any clinically significant immunological disorder/disease (such as allergy, atopy, autoimmune diseases, etc.), cardiovascular, thromboembolic events, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (particularly diabetes or pre-diabetes), hematological, dermatological, venereal, neurological, chronic infectious or psychiatric disease or other major disorder. A history of childhood asthma, hay fever or mild eczema may be acceptable at the discretion of the investigator.
• History of cancer, including any form of skin cancer, which has not been in remission for at least 5 years prior to the first dose of study product.
• History of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or non-peripheral vascular surgery within 6 months prior to the first dose of study product.
• Current history of asthma and any skin disease. A history of childhood asthma or mild eczema may be acceptable at the discretion of the investigator.
• The subject's corrected QT interval (QTcF) (Fridericia's correction) is >450 ms at screening and on Day -1. An out-of-range or abnormal ECG should be repeated. In total, 3 ECGs should be recorded consecutively, and the Investigator must evaluate the triplicate ECG. If the subject's QTcF is >450 ms on at least 2 ECGs, the subject must be excluded.
• Prior exposure to NJA-730 or any other systemic immunosuppressive agent in the last 6 months or 5 half-lives (whichever is longer).
• The subject has taken prescription or non-prescription medication, herbal remedies, vitamins or minerals within 2 weeks prior to the first dose of study product (or within 5 half-lives prior to the first dose of study product for any
• medication ingested, whichever is longer) without approval of the Investigator, NapaJen representative and medical monitor.
• The subject has a history of significant hypersensitivity or anaphylaxis involving any drug, food or other precipitating agent (e.g. bee sting).
• The subject has any abnormal laboratory values that, in the opinion of the primary Investigator, are deemed clinically significant and would preclude participation in the study.
• The subject has any concurrent illness that may affect the
• particular target or absorption, distribution, and elimination of the study product.
• The subject has had a clinically significant illness within 4 weeks prior to the first dose of study product.
• Any major surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study product.
• Blood donation of 500 mL within 3 months prior to the first dose of study product.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at screening.
• Any history of tuberculosis (TB), whether treated or untreated (and/or a positive QuantiFERON®-TB Gold blood test).
• Chest x-ray undertaken 3 months prior to screen or at screening showing signs of inflammation, infection or malignancy.
• A history of recurrent and/or severe infections, including any significant infection in the previous 6 months.
• The subject has a substance abuse-related disorder or has
• a history of drug, alcohol and/or substance abuse deemed significant by the Investigator.
• Positive screen for drugs of abuse or alcohol at screening and on Day -1.
• The subject is, in the opinion of the Investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
• Employees of the Investigator or study center, as well as first degree family members of the employees or the Investigator.