Status and phase
Conditions
Treatments
About
The purpose of this study is to evaluate the safety, tolerability, pharmakokinetics and pharmacodynamics of single and repeated doses of ANX009
Full description
In this first in human, phase 1, randomized, double-blind, placebo-controlled study, single and multiple ascending doses of ANX009 or placebo will be administered to 48 healthy subjects.
Single Ascending Dose (SAD): Each SAD subject will participate for approximately 4 weeks (3 nights in-clinic confinement).
Multiple Ascending Dose: Each MAD subject will participate for approximately 6 weeks (17 nights in-clinic confinement).
All subjects will be contacted (in clinic visit or phone call) 6 months after study completion.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subjects must not meet any of the following criteria:
Primary purpose
Allocation
Interventional model
Masking
48 participants in 4 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal