Dose Escalation, MTD, Safety and PK Study of a Single Dose SC Injection of TransCon PEG Treprostinil in Healthy Male Volunteers

Exclusion Criteria

• •1. Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations
• •2. Subject has a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug
• •3. Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not
• •4. Subject has a history of postural hypotension, or unexplained syncope
• •5. Subject has a blood pressure that is less than 85 mmHg systolic or 50 mmHg diastolic at Screening or Baseline
• •6. Subject has a pulse rate that is greater than 90 bpm after sitting at rest for 5 minutes at Screening or Baseline
• •7. Subject has a history of hypertension
• •8. Subject has a blood pressure that is greater than 150 mmHg systolic or 90 mmHg diastolic at Screening or Baseline
• •9. Subject has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs
• •10. Subject has tested positive at the screening visit for HIV infection, HBsAg, or the HCV antibody
• •11. Subject currently uses tobacco products or has a history of tobacco use within six months prior to Baseline
• •12. Subject has a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse
• •13. Subject has a history of or current evidence of abuse of licit or illicit drugs or a positive urine screen for drugs of abuse
• •14. Subject has a history of abnormal bleeding tendencies
• •15. Subject has donated blood or plasma or has lost a significant volume of blood (greater than 450 mL) within four weeks prior to Baseline
• •16. Subject has participated in any investigational drug study within 30 days prior to Screening