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

ClinicalTrials.gov ID: NCT04742517

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04742517
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Astellas Pharma Europe B.V.; Industry
Enrollment: 102 participants

Conditions and interventions

Conditions

Healthy Volunteers

Interventions

ASP1128 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 20, 2017 (Actual)
Primary completion: Sep 7, 2018 (Actual)
Completion: Sep 7, 2018 (Actual)
Last update posted: Nov 18, 2024

2017 – 2018

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Parexel Early Phase Clinical Unit - Los Angeles	Glendale	California	91206	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04742517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 18, 2024 · Synced Nov 15, 2026