drugset
drugset / Trial / NCT02681861

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects

NCT02681861 ↗

Phase 1 Completed 74 enrolled Astellas Pharma Europe B.V.
RandomizedParallel-groupQuadruple-blindBasic science

Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and female subjects. This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous doses and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF); explore a potential gender difference in safety, tolerability and pk of single intravenous dose and single sc doses administrations of ASP6294 as well as determine the maximum tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294. Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc.

Timeline

Start
2016-01
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP6294 Unknown — Intravenous

Indications

No indication recorded.