Status:
COMPLETED
Safety and Tolerability of an Antibody Against Yellow Fever Virus (TY014) in Humans
Lead Sponsor:
Tysana Pte Ltd
Conditions:
Treatment of Acute Yellow Fever Virus Infection
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief 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 (...
Detailed Description
Safety Arm (1A): Safety Arm is a phase 1A First-in-Human, Time Lagged, Single Ascending Dose Study of TY014 in Healthy Adult Volunteers. Safety, tolerability and PK of TY014 will be assessed. The do...
Eligibility Criteria
Inclusion
- 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
- Accessible vein in the forearm for blood collection
- Female subjects of childbearing potential may be enrolled in the study if they have negative urine pregnancy tests on the day of screening and day of admission
- Female subjects of non-childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Post-menopause subjects must have had at least 12 months of natural (spontaneous) amenorrhea
- Both male (if he has a partner of childbearing potential) and female subjects (of childbearing potential) must agree to use adequate and reliable contraceptive measures (e.g. spermicides, condoms, contraceptive pills, etc.) or practice abstinence throughout the duration of the study (up to 84 days post-dosing)
Exclusion
- 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
- Administration of any licensed vaccine within 30 days before the first study vaccine dose.
- History of any reaction to monoclonal antibodies
- Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the subject
- Both male (if he has a partner of childbearing potential) and female subjects (of childbearing potential) who are unwilling to use adequate contraception or practice abstinence throughout the duration of the study (up to 84 days post-dosing)
- Efficacy Arm (1B) only:
- Subjects meeting any of the following criteria will be excluded from the study:
- Planned travels to Central America, South America, Africa or any other YFV-endemic countries in the next six (6) months
- History of thymus gland disease.
- Diagnosed with cancer or on treatment for cancer with the three (3) years prior to the screening.
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03776786
Start Date
December 6 2018
End Date
October 10 2019
Last Update
October 25 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SingHealth Investigational Medicine Unit
Singapore, Singapore, 169608