A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test ACE-031.

It had 1 arm (groups): single (experimental).

8 subjects (6 active and 2 placebo).

The registry classes the interventions as biological.

Who Took Part

The registry lists 48 actual participants took part.

It was open to women only aged from 45 years up to 75 years.

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

Examples of who could join: Subject is a postmenopausal woman, 45-75 years old (inclusive). Subject has a body mass index (BMI) of \> 18.5 to \< 30. Subject must give written informed consent.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia); subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening; subject has a history of severe allergic or anaphylactic reactions.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

The participants were allocated by chance, so the ACE-031 group and the comparison group should start out alike.

As a double-blind ACE-031 study, the assignments were hidden from both participants and investigators until the end.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2008-09 with completion listed for 2009-07.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of ACE-031 in 48 people.

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

More context: the ACE-031 compound page, all human trials.