Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

NCT ID: NCT05088369

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2022-12-19

Brief Summary

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.

Detailed Description

Objective of the study is to assess the safety, tolerability, and PK of single and multiple intravenous administration of HM201. The study design consists of a SAD study of 4 cohorts, 8 subjects each cohort and a different dose level per cohort. In each cohort 2 will receive the placebo while rest of group will be administered with HM201. A total of 32 subjects are planned for the SAD study.

MAD part will begin after cohort 1 and 2 of SAD is completed. MAD will consist of 8 subjects; 2 will receive the placebo while 6 will be administered with HM201. MAD will be conducted in a dose escalation manner with 4 weekly doses administered to all subjects. One randomization scheme will be produced for each cohort separately.

Conditions

Ulcerative Colitis; Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAD Cohorts 1 to 4: Participants receiving HM201

Each SAD cohort participant will be randomized to receive 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg); 0.12 mg/kg (20 nmol/kg).

Group Type: EXPERIMENTAL

HM201

Intervention Type: DRUG

HM201 will be administered intravenously.

SAD Cohorts 1 to 4: Participants Receiving Placebo

Each SAD cohort participant will be randomized to receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered intravenously.

MAD Cohorts 1 to 4: Participants Receiving HM201

Each MAD cohort participant will be randomized to receive a once a week dose of 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg), 0.12 mg/kg (20 nmol/kg) for 4 weeks.

Group Type: EXPERIMENTAL

HM201

Intervention Type: DRUG

HM201 will be administered intravenously.

MAD Cohorts 1 to 4: Participants Receiving Placebo

Each MAD cohort participant will be randomized to receive placebo once a week for 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered intravenously.

Interventions

HM201

HM201 will be administered intravenously.

Intervention Type: DRUG

Placebo

Placebo will be administered intravenously.

Intervention Type: DRUG

HM201

HM201 will be administered intravenously.

Intervention Type: DRUG

Placebo

Placebo will be administered intravenously.

Intervention Type: DRUG

Other Intervention Names

Pegylated human adrenomedullin; Matching Placebo; Pegylated human adrenomedullin; Matching Placebo

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Himuka AM Pharma Corp.

UNKNOWN

Sponsor Role: collaborator

Syneos Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristi McLendon, MD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Pty Ltd.

Locations

Nucleus Network Pty Ltd

Herston, Queensland, Australia

Countries

Australia

Other Identifiers

HM201-AUS-001

Identifier Type: -

Identifier Source: org_study_id