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Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

Primary Purpose

Ulcerative Colitis, Crohn's Disease

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

HM201

Placebo

HM201

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

Healthy male or non-childbearing potential female
BMI ≥18.0 and ≤32.0 kg/m2
Good health based on past medical history, medication use, vital signs and physical exam.
Normal renal and hepatic function.
Female partners of child bearing potential must agree to use contraception.

Key Exclusion Criteria:

Clinically significant medical history.
Significant drug allergy.
Use of experimental drug within 3 months prior.
Previously received HM201, AM and other derivatives.
History of old myocardial infarction.
Diagnosed with malignant tumor or history of treatment for malignant tumor.
History of drug or alcohol abuse.
Use of omitted medicines or substance opposing objective of study.
COVID19 vaccine administered within 14 days of initiation of investigational product or if to receive additional dose within 30 days of investigational product administration.
Use of tobacco/nicotine in excess of ≥ 5 cigarettes a day and unable or unwilling to prohibit smoking during admission to site.
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.
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.
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.
Clinically relevant findings in ECG.
Systolic blood pressure below 100 mmHg or above 140 mmHg at screening.
Diastolic blood pressure above 90 mmHg at screening.
Heart rate below 40 beats/min or above 100 beats/min at screening.
Symptom of orthostatic hypotension is found at screening or before investigational product administration (Day -1).
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.
Positive to syphilis.
Positive to urine drug test.
Positive alcohol breath test.

Sites / Locations

Nucleus Network Pty Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

SAD Cohorts 1 to 4: Participants receiving HM201

SAD Cohorts 1 to 4: Participants Receiving Placebo

MAD Cohorts 1 to 4: Participants Receiving HM201

MAD Cohorts 1 to 4: Participants Receiving Placebo

Arm Description

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).

Each SAD cohort participant will be randomized to receive placebo.

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.

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

Outcomes

Primary Outcome Measures

Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation.

Secondary Outcome Measures

Plasma concentrations of HM201

Pharmacokinetic assessment 1

Area under the plasma concentration versus time curve (AUC)

Pharmacokinetic assessment 2

Peak Plasma Concentration (Cmax)

Pharmacokinetic assessment 3

Time of peak plasma concentration (Tmax)

Pharmacokinetic assessment 4

Concentration at the last planned timepoint prior to dosing (Ctrough)

Pharmacokinetic assessment 5

Mean residence time (MRT)

Pharmacokinetic assessment 6

Drug clearance (CL) & Clearance at steady state (CLss)

Pharmacokinetic assessment 7

Volume of distribution at steady state (Vss) & during terminal phase (VZ)

Pharmacokinetic assessment 8

Half life (T1/2)

Full Information

NCT ID

NCT05088369

First Posted

October 12, 2021

Last Updated

January 30, 2023

Sponsor

Syneos Health

Collaborators

Himuka AM Pharma Corp.

1. Study Identification

Unique Protocol Identification Number

NCT05088369

Brief Title

Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

November 11, 2021 (Actual)

Primary Completion Date

December 19, 2022 (Actual)

Study Completion Date

December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syneos Health

Collaborators

Himuka AM Pharma Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Crohn's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

SAD & MAD study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAD Cohorts 1 to 4: Participants receiving HM201

Arm Type

Experimental

Arm Description

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).

Arm Title

SAD Cohorts 1 to 4: Participants Receiving Placebo

Arm Type

Placebo Comparator

Arm Description

Each SAD cohort participant will be randomized to receive placebo.

Arm Title

MAD Cohorts 1 to 4: Participants Receiving HM201

Arm Type

Experimental

Arm Description

Arm Title

MAD Cohorts 1 to 4: Participants Receiving Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HM201

Other Intervention Name(s)

Pegylated human adrenomedullin

Intervention Description

HM201 will be administered intravenously.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Matching Placebo

Intervention Description

Placebo will be administered intravenously.

Intervention Type

Drug

Intervention Name(s)

HM201

Other Intervention Name(s)

Pegylated human adrenomedullin

Intervention Description

HM201 will be administered intravenously.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Matching Placebo

Intervention Description

Placebo will be administered intravenously.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Plasma concentrations of HM201

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

Title

Pharmacokinetic assessment 1

Description

Area under the plasma concentration versus time curve (AUC)

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

Title

Pharmacokinetic assessment 2

Description

Peak Plasma Concentration (Cmax)

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

Title

Pharmacokinetic assessment 3

Description

Time of peak plasma concentration (Tmax)

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

Title

Pharmacokinetic assessment 4

Description

Concentration at the last planned timepoint prior to dosing (Ctrough)

Time Frame

MAD: Up to Day 36

Title

Pharmacokinetic assessment 5

Description

Mean residence time (MRT)

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

Title

Pharmacokinetic assessment 6

Description

Drug clearance (CL) & Clearance at steady state (CLss)

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

Title

Pharmacokinetic assessment 7

Description

Volume of distribution at steady state (Vss) & during terminal phase (VZ)

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

Title

Pharmacokinetic assessment 8

Description

Half life (T1/2)

Time Frame

SAD: Up to Day 15. MAD: Up to Day 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Healthy male or non-childbearing potential female BMI ≥18.0 and ≤32.0 kg/m2 Good health based on past medical history, medication use, vital signs and physical exam. Normal renal and hepatic function. Female partners of child bearing potential must agree to use contraception. Key Exclusion Criteria: Clinically significant medical history. Significant drug allergy. Use of experimental drug within 3 months prior. Previously received HM201, AM and other derivatives. History of old myocardial infarction. Diagnosed with malignant tumor or history of treatment for malignant tumor. History of drug or alcohol abuse. Use of omitted medicines or substance opposing objective of study. COVID19 vaccine administered within 14 days of initiation of investigational product or if to receive additional dose within 30 days of investigational product administration. Use of tobacco/nicotine in excess of ≥ 5 cigarettes a day and unable or unwilling to prohibit smoking during admission to site. 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. 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. 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. Clinically relevant findings in ECG. Systolic blood pressure below 100 mmHg or above 140 mmHg at screening. Diastolic blood pressure above 90 mmHg at screening. Heart rate below 40 beats/min or above 100 beats/min at screening. Symptom of orthostatic hypotension is found at screening or before investigational product administration (Day -1). 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. Positive to syphilis. Positive to urine drug test. Positive alcohol breath test.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristi McLendon, MD

Organizational Affiliation

Nucleus Network Pty Ltd.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nucleus Network Pty Ltd

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

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