Safety and Tolerability of an Antibody Against Zika Virus (Tyzivumab) in Humans
Status:
Completed
Trial end date:
2018-12-04
Target enrollment:
Participant gender:
Summary
Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector
that transmits Dengue virus, Aedes aegypti. ZIKV is a growing public health problem, rapidly
spreading throughout the continents since the first epidemic was reported in the French
Polynesian islands.
Currently, there are several ZIKV vaccine candidates in clinical trials. However, no ZIKV
therapy (biologic or small molecule) has advanced to clinical trials. Tyzivumab will be the
first therapeutic in the world, specifically targeting ZIKV, to enter clinical trials.
This is a Phase 1, first in human, time-lagged, parallel-group, single dose ascending (6 dose
cohorts), Tyzivumab, ZIKV monoclonal antibody (mAb), study to be conducted in 24 flaviviral
naïve healthy adult volunteers.
Tyzivumab will be administered once through single IV infusion over 30 minutes. Total
duration of study participation is estimated at approximately 98 days from the date of
screening. Post-trial monitoring through weekly telephone calls will continue from Day 85
post-dose onwards for another three (3) more months.
The main objective of this study is to evaluate safety of Tyzivumab in healthy adult
volunteers through assessment of subject vital signs, clinical laboratory results, ECG,
presence/absence of AE/SAE, PK and ADA.
Phase:
Phase 1
Details
Lead Sponsor:
Tychan Pte Ltd.
Collaborators:
Duke-NUS Graduate Medical School National University Hospital, Singapore National University, Singapore Singapore Clinical Research Institute