NCT05088369

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	HM201	HM201 will be administered intravenously.
DRUG	Placebo	Placebo will be administered intravenously.
DRUG	HM201	HM201 will be administered intravenously.
DRUG	Placebo	Placebo will be administered intravenously.

Timeline

• Start date: 2021-11-11
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2021-10-21
• Last updated: 2023-02-01

Locations

1 site across 1 country: Australia