Status:
COMPLETED
Safety and Tolerability of an Antibody Against Zika Virus (Tyzivumab) in Humans
Lead Sponsor:
Tychan Pte Ltd.
Collaborating Sponsors:
Duke-NUS Graduate Medical School
Singapore Clinical Research Institute
Conditions:
Treatment of Acute Zika Virus Infection
Eligibility:
All Genders
21-45 years
Phase:
PHASE1
Brief 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 throug...
Detailed Description
Dose escalation in this study will include 24 healthy volunteers in six (6) dose cohorts: * 0.2 mg/kg, N = 2 * 0.5 mg/kg, N = 2 * 1 mg/kg, N = 2 * 5 mg/kg, N = 6 * 10 mg/kg, N = 6 * 20 mg/kg, N = 6 ...
Eligibility Criteria
Inclusion
- Each subject must meet all the following criteria to be enrolled:
- Adult healthy volunteers, aged 21 to 45, men or women
- a. Women must fulfil one (1) of the following criteria: i. Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone \> 40 mIU/mL ii. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation iii.Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening day until 100 days post-infusion b. Male subjects who are non-vasectomized (or vasectomized less than six (6) months prior to dosing) and have female partners of childbearing potential must be willing to use an effective birth control method when having heterosexual intercourse, from screening day until 100 days post-infusion
- Subjects negative for antibodies to flaviviruses as measured by a commercially available Dengue virus IgG enzyme-linked immunosorbent assay (ELISA) diagnostic kit
- Subjects negative for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV)
- Subjects who are willing to comply with the requirements of the study protocol and attend scheduled visit
- 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 normal laboratory values or minor variations that are acceptable for study entry
- Accessible vein in the forearm for blood collection
Exclusion
- Subjects meeting any of the following criteria will be excluded from the study:
- 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
- Planned administration of any vaccine not foreseen by the study protocol 12 weeks before first dosing day and up to four (4) months after dosing
- 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
- History of any reaction to monoclonal antibodies
- Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception
- Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the subject
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03443830
Start Date
February 8 2018
End Date
December 4 2018
Last Update
April 10 2019
Active Locations (1)
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1
SingHealth Investigational Medicine Unit
Singapore, Singapore, 169608