TY014 will be the first therapeutic in the world, specifically targeting Yellow Fever Virus (YFV), to enter clinical trials. It is anticipated that a monoclonal antibody therapeutic could be administered to infected cases to reduce disease severity within the patient and their contacts.
Although there is currently a safe and effective vaccine available on the market, global shortages of supplies have severely hampered any efforts in the prevention and control of YFV outbreaks.
To date, no YFV therapy (biologic or small molecule) has advanced to clinical trials.
This is a Phase 1, first-in-human TY014, YFV monoclonal antibody (mAb), study to be conducted in two (2) arms:
- Safety Arm (1A): Healthy adult volunteers
- Efficacy Arm (1B): Healthy adult volunteers challenged with YF-17D Vaccine Strain 24 hours prior to TY014 dosing
TY014 will be administered once through a single IV infusion over 30 minutes. The total duration of study participation is estimated at approximately 114 days from the date of screening.
The main objectives of this study are:
- Evaluate the safety of TY014 in healthy adult volunteers
- Evaluate the safety of TY014 in YF-17D Vaccine Strain-challenged healthy adult volunteers.
- Percentage aviremia of YF-17D Vaccine Strain-challenged subjects within 48 hours after IV infusion of TY014 will also be assessed.
Clinical Trial NCT03776786: Safety and Tolerability of an Antibody Against Yellow Fever Virus (TY014) in Humans