Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
The study consists of two parts: Part 1 (ascending intravenous dose) and Part 2 (ascending subcutaneous dose). Subjects will participate in either Part 1 or Part 2. Subjects in Part 1 and Part 2 will have a residential period of 6 days followed by outpatient visits.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject has a body mass index range of 18.5 - 30.0 kg/m2, inclusive, and the subject weighs at least 50 kg (at screening).
Female subject must either:
Female subject must agree not to breastfeed starting at screening and throughout the clinical study period, and for 120 days after final study drug administration.
Female subject must not donate ova starting at screening and throughout the clinical study period, and for 120 days after final study drug administration.
Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective form of birth control† in combination with a barrier method starting at screening and throughout the clinical study period and for 120 days after final study drug administration.
Male subject must not donate sperm starting at screening and throughout the clinical study period and for 120 days after final study drug administration.
Subject agrees not to participate in another interventional study during participation in the present study, defined as signing the informed consent form until completion of the last study visit.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
74 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal