NCT04742517

A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects

A Phase 1 Combined Single and Multiple Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0217 in Healthy Adult Subjects and Healthy Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses of ASP1128 in healthy adult male and female subjects and multiple ascending intravenous doses of ASP1128 in healthy adult male and female subjects and healthy elderly male and female subjects. This study will also evaluate the pharmacokinetics and the effect on the QT interval using Fridericia's correction formula (QTcF) in these subjects.

Detailed description

After a screening period of up to 28 days prior to study drug administration, eligible participants will be residential for a single period of 5 days/4 nights in Part 1: single ascending dose, and 11 days/10 nights in Part 2 multiple ascending dose. Part 1 is composed of 6 parallel cohorts (cohorts 1.1 to 1.6) and up to 2 optional cohorts (cohorts 1.7 and 1.8) of 8 healthy adult male and female subjects in each cohort. If the data from cohorts 1.1 to 1.6 are not sufficient to characterize safety, tolerability and pharmacokinetics, up to 2 optional cohorts (cohorts 1.7 and 1.8) may be added. Part 2 is composed of 4 parallel cohorts (cohorts 2.1 to 2.4) and 1 optional cohort (cohort 2.5) of 12 healthy adult male and female subjects in each cohort and 1 cohort (cohort 2.6) of 12 healthy elderly male and female subjects. Dosing of the elderly cohort (cohort 2.6) will commence after having established the safety and tolerability of the corresponding dose tested in cohorts 2.1 to 2.5. If the data from cohorts 2.1 to 2.4 are not sufficient to characterize safety, tolerability and pharmacokinetics, 1 optional cohort (cohort 2.5) may be added.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ASP1128	Intravenous
DRUG	Placebo	Intravenous

Timeline

• Start date: 2017-11-20
• Primary completion: 2018-09-07
• Completion: 2018-09-07
• First posted: 2021-02-08
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study