Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05088369




Registration number
NCT05088369
Ethics application status
Date submitted
12/10/2021
Date registered
21/10/2021
Date last updated
1/02/2023

Titles & IDs
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)
Secondary ID [1] 0 0
HM201-AUS-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HM201
Treatment: Drugs - Placebo
Treatment: Drugs - HM201
Treatment: Drugs - Placebo

Experimental: 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).

Placebo Comparator: SAD Cohorts 1 to 4: Participants Receiving Placebo - Each SAD cohort participant will be randomized to receive placebo.

Experimental: 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.

Placebo Comparator: MAD Cohorts 1 to 4: Participants Receiving Placebo - Each MAD cohort participant will be randomized to receive placebo once a week for 4 weeks.


Treatment: Drugs: HM201
HM201 will be administered intravenously.

Treatment: Drugs: Placebo
Placebo will be administered intravenously.

Treatment: Drugs: HM201
HM201 will be administered intravenously.

Treatment: Drugs: Placebo
Placebo will be administered intravenously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation.
Timepoint [1] 0 0
Up to 15 days post last infusion for both SAD & MAD
Secondary outcome [1] 0 0
Plasma concentrations of HM201
Timepoint [1] 0 0
SAD: Up to Day 15. MAD: Up to Day 36
Secondary outcome [2] 0 0
Pharmacokinetic assessment 1
Timepoint [2] 0 0
SAD: Up to Day 15. MAD: Up to Day 36
Secondary outcome [3] 0 0
Pharmacokinetic assessment 2
Timepoint [3] 0 0
SAD: Up to Day 15. MAD: Up to Day 36
Secondary outcome [4] 0 0
Pharmacokinetic assessment 3
Timepoint [4] 0 0
SAD: Up to Day 15. MAD: Up to Day 36
Secondary outcome [5] 0 0
Pharmacokinetic assessment 4
Timepoint [5] 0 0
MAD: Up to Day 36
Secondary outcome [6] 0 0
Pharmacokinetic assessment 5
Timepoint [6] 0 0
SAD: Up to Day 15. MAD: Up to Day 36
Secondary outcome [7] 0 0
Pharmacokinetic assessment 6
Timepoint [7] 0 0
SAD: Up to Day 15. MAD: Up to Day 36
Secondary outcome [8] 0 0
Pharmacokinetic assessment 7
Timepoint [8] 0 0
SAD: Up to Day 15. MAD: Up to Day 36
Secondary outcome [9] 0 0
Pharmacokinetic assessment 8
Timepoint [9] 0 0
SAD: Up to Day 15. MAD: Up to Day 36

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2022
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Himuka AM Pharma Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05088369
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristi McLendon, MD
Address 0 0
Nucleus Network Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries