Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

What Was Tested

This registered phase 1 trial tested Adrenomedullin for gut: ibd (crohn's, colitis), leaky gut, ibs & ulcers.

It had four arms (groups): SAD Cohorts 1 to 4: Participants receiving HM201 (experimental), SAD Cohorts 1 to 4: Participants Receiving Placebo (placebo comparator), MAD Cohorts 1 to 4: Participants Receiving HM201 (experimental) and MAD Cohorts 1 to 4: Participants Receiving Placebo (placebo comparator).

Each SAD cohort participant will be randomized to receive placebo.

The registry classes the interventions as drug.

More on the Plan

Objective of the study is to assess the safety, tolerability, and PK of single and multiple intravenous administration of HM201.

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.

Who Took Part

The registry lists 53 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI ≥18.0 and ≤32.0 kg/m2. Normal renal and hepatic function. Female partners of child bearing potential must agree to use contraception.

The full record lists 5 inclusion and 22 exclusion criteria; among the exclusions: use of experimental drug within 3 months prior; previously received hm201, am and other derivatives; history of old myocardial infarction.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Adrenomedullin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Adrenomedullin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the gut: ibd (crohn's, colitis), leaky gut, ibs & ulcers participants and researchers unaware of who received Adrenomedullin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-11-11 with completion listed for 2022-12-19.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 9 secondary outcomes, for example Plasma concentrations of HM201.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Adrenomedullin in 53 people with gut: ibd (crohn's, colitis), leaky gut, ibs & ulcers.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Adrenomedullin compound page, Gut: IBD (Crohn's, colitis), leaky gut, IBS & ulcers research.