Safety and Tolerability of an Antibody Against Yellow Fever Virus (TY014) in Humans (NCT03776786) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of an Antibody Against Yellow Fever Virus (TY014) in Humans
Singapore37 participantsStarted 2018-12-06
Plain-language summary
Yellow Fever is an acute viral hemorrhagic disease caused by the Yellow Fever Virus (YFV), a re-emerging arbovirus transmitted by the same mosquito vector (Aedes aegypti) that transmits Dengue virus (DENV) and Zika virus (ZIKV). YFV is endemic in tropical and subtropical areas of South America and Africa, causing an estimated 200,000 infections and 30,000 deaths annually. It has now become a growing public health problem, rapidly spreading throughout the two (2) continents in a cyclical pattern. With climate change, global travel and urbanisation, which increase the chance for mosquito-borne diseases to spread rapidly, the risk of YFV establishing its foothold in the Asia-Pacific region with periodic epidemic bursts remains a real public health concern.
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. TY014 will be the first therapeutic in the world, specifically targeting 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.
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 single IV infusion over 30 minutes. Total duration of study participation is estimated at approximately 114 days from the date of screening.
The main objectives of this study are to: (a) evaluate the safety of TY014 in healthy adult volunteers, and (b) 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.
Who can participate
Age range21 Years – 50 Years
SexALL
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Inclusion criteria
✓. Healthy adult volunteers, aged 21 to 50 years old, men or women
✓. Subjects negative for human immunodeficiency virus (HIV), Hepatitis B virus surface Antigen (HBsAg) and Hepatitis C virus (HCV)
✓. Subjects who have not been vaccinated against or had prior exposure to Yellow Fever Virus (YFV)
✓. Subjects who have no history of travels to Central America, South America, Africa or any other YF endemic countries, and have no plans to visit Central America, South America, Africa or any other YF endemic countries in the next six (6) months
✓. Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and make themselves available for the duration of the study with access to a consistent means of telephone contact, which may be, but not limited to, at home or at work via landline or mobile
✓. Subjects who give written informed consent approved by the Ethical Review Board governing the site
✓. Satisfactory baseline medical assessment as assessed by physical examination and a stable health status. Normal laboratory values must be within normal range of the assessing site or show minor variations that are deemed not clinically significant as judged by the Investigator and acceptable for study entry. A stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event
What they're measuring
1
Incidence of Treatment-Emergent Adverse Event (Safety and Tolerability)
Timeframe: 84 Days
2
Percentage Aviremia Post Treatment (Efficacy Arm only)
✓. Accessible vein in the forearm for blood collection
Exclusion criteria
✕. Presence of acute infection in the preceding 14 days, or presence of a temperature ≥ 38.0 ˚C (oral or tympanic temperature assessment), or acute symptoms greater than of "mild" severity on the scheduled date of admission
✕. History of severe drug and / or food allergies and / or known allergies to the trial product or its components
✕. Female subject who is pregnant or breast-feeding
✕. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, or immunosuppressive disorders
✕. Evidence of clinically significant anaemia (HB \< 10 g/dL) or any other significant active haematological disease, or having donated \> 450 mL of blood within the past three (3) months
✕. Evidence of substance abuse, or previous substance abuse
✕. Participation or planned participation in a study involving the administration of an investigational compound within the past four (4) months or during this study period
✕. Receipt of immunoglobulins and/or any blood products within nine (9) months of study enrolment or planned administration of any of these products during the study period