A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults)

HM201-AUS-001

This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD \& MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.

2021-11-11

2022-12-19

2022-12-19

Completed

Early phase I

53

Key Inclusion Criteria: 1. Healthy male or non-childbearing potential female 2. BMI ≥18.0 and ≤32.0 kg/m2 3. Good health based on past medical history, medication use, vital signs and physical exam. 4. Normal renal and hepatic function. 5. Female partners of child bearing potential must agree to use contraception. Key Exclusion Criteria: 1. Clinically significant medical history. 2. Significant drug allergy. 3. Use of experimental drug within 3 months prior. 4. Previously received HM201, AM and other derivatives. 5. History of old myocardial infarction. 6. Diagnosed with malignant tumor or history of treatment for malignant tumor. 7. History of drug or alcohol abuse. 8. Use of omitted medicines or substance opposing objective of study. 9. COVID19 vaccine administered within 14 days of initiation of investigational product or if to receive additional dose within 30 days of investigational product administration. 10. Use of tobacco/nicotine in excess of ≥ 5 cigarettes a day and unable or unwilling to prohibit smoking during admission to site. 11. Daily consumption of more than 1L of caffeine/xanthine beverage which cannot be discontinued more than 24 hours prior to dosing of investigational product and/or ECG measurement. 12. Regular use of nutraceuticals (e.g., St. John's wort, ginseng, ginkgo biloba, Chinese herbs, and melatonin) within 1 week before administration of investigational product. 13. Donation of plasma or platelet or 200 mL of whole blood within 4 weeks or 400 mL whole blood within 3 months before administration of investigational product. 14. Clinically relevant findings in ECG. 15. Systolic blood pressure below 100 mmHg or above 140 mmHg at screening. 16. Diastolic blood pressure above 90 mmHg at screening. 17. Heart rate below 40 beats/min or above 100 beats/min at screening. 18. Symptom of orthostatic hypotension is found at screening or before investigational product administration (Day -1). 19. Hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb) hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV) antigen and antibody at screening. 20. Positive to syphilis. 21. Positive to urine drug test. 22. Positive alcohol breath test.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SAD \\& MAD study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "This study will be conducted as a double-blind study. All subjects and clinical personnel will involved in the collection, monitoring, revision, safety and adverse events will be blinded in regards to the subject's treatment assigned of HM201 or the HM201 placebo. All personnel affecting the outcome of the study's treatment assignment will be blinded.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 53, 'type': 'ACTUAL'}}

2023-02-01