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Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

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)

NCT05088369•Syneos Health

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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.
+12 more criteria

Locations (1)

Nucleus Network Pty Ltd

Herston, Queensland, Australia

Key Dates

Start Date

November 11, 2021

Primary Completion Date

December 19, 2022

Completion Date

December 19, 2022

Last Updated

February 1, 2023

Enrollment

ACTUAL participants

Conditions

Ulcerative ColitisCrohn's Disease

Interventions

HM201

DRUG

Placebo

DRUG

HM201

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

Inclusion Criteria

Exclusion Criteria

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