Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

NCT05088369 | Completed Phase 1

• 1 other identifier: HM201-AUS-001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

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

  Up to 15 days post last infusion for both SAD & MAD

Secondary Outcomes (9)

• Plasma concentrations of HM201

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

• Pharmacokinetic assessment 1

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

• Pharmacokinetic assessment 2

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

• Pharmacokinetic assessment 3

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

• Pharmacokinetic assessment 4

  MAD: Up to Day 36

Study Arms (4)

SAD Cohorts 1 to 4: Participants receiving HM201

EXPERIMENTAL

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).

Drug: HM201

SAD Cohorts 1 to 4: Participants Receiving Placebo

PLACEBO COMPARATOR

Each SAD cohort participant will be randomized to receive placebo.

Drug: Placebo

MAD Cohorts 1 to 4: Participants Receiving HM201

EXPERIMENTAL

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.

Drug: HM201

MAD Cohorts 1 to 4: Participants Receiving Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HM201 DRUG

HM201 will be administered intravenously.

Also known as: Pegylated human adrenomedullin

SAD Cohorts 1 to 4: Participants receiving HM201

Placebo DRUG

Placebo will be administered intravenously.

Also known as: Matching Placebo

SAD Cohorts 1 to 4: Participants Receiving Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syneos Health: lead
• Himuka AM Pharma Corp.: collaborator

Study Sites (1)

Nucleus Network Pty Ltd

Herston, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Kristi McLendon, MD

  Nucleus Network Pty Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SAD \& MAD study

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 21, 2021
• Study Start: November 11, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

AU (1)