Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

• Register: ClinicalTrials.gov
• Last refreshed on: 13 February 2023
• Main ID: NCT05088369
• Date of registration: 12/10/2021
• Prospective Registration: Yes
• Primary sponsor: Syneos Health
• Public title: Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201
• Scientific title: 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)
• Date of first enrolment: November 11, 2021
• Target sample size: 53
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05088369
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Kristi McLendon, MD
• Affiliation: Nucleus Network Pty Ltd

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Ulcerative Colitis

Intervention(s)

Drug: HM201

Drug: Placebo

Primary Outcome(s)

Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation. [Time Frame: Up to 15 days post last infusion for both SAD & MAD]

Secondary Outcome(s)

Pharmacokinetic assessment 2 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Pharmacokinetic assessment 8 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Pharmacokinetic assessment 6 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Pharmacokinetic assessment 7 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Pharmacokinetic assessment 1 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Pharmacokinetic assessment 3 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Pharmacokinetic assessment 4 [Time Frame: MAD: Up to Day 36]

Pharmacokinetic assessment 5 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Plasma concentrations of HM201 [Time Frame: SAD: Up to Day 15. MAD: Up to Day 36]

Secondary ID(s)

HM201-AUS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Himuka AM Pharma Corp.