Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029

An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00563810

Enrollment

Registered

2007-11-26

Start date

2004-10-31

Completion date

2006-04-30

Last updated

2007-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Adult, Aged

Brief summary

This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational new drug.

Interventions

DRUGMYO-029

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Men aged 18 to 45 years inclusive on study day 1. * Elderly men and women aged 65 to 80 years inclusive on study day 1. * Women must be postmenopausal for \> or = 1 year (with estradiol \< 25 pg/mL and an FSH \> 40 mIU/mL). * Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, clinical laboratory test results, and 12-leave electrocardiogram. * Elderly subjects may have stable, nonclinically significant abnormalities on physical examination, and laboratory evaluation. * Non-smoker.

Design outcomes

Primary

Measure	Time frame
To assess safety and tolerability.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026