Safety Study of Dengushield in Healthy Adults

This Phase 1 study will evaluate the safety and tolerability of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults in a dose-escalating study design. In addition, pharmacokinetics will also be studied.

Inclusion criteria

• Healthy adults aged 18-45 years, men, or women.
• Negative Dengue NS1 at screening indicating no current dengue infection
• Seronegative for dengue IgG
• Participants who are willing to comply with the requirements of the study protocol and attend scheduled visit.
• Participants who give written informed consent.
• Participants having laboratory parameters within normal range
• Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
• Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that is acceptable for study entry.

Exclusion criteria

• Presence of acute infection in the preceding 14 days or presence of a temperature ≥ 38.0°C, or acute symptoms of infection greater than of "mild" severity on the scheduled date of first dosing
• History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
• Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
• Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
• Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
• Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing except for influenza vaccination.
• Receipt of immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
• Laboratory confirmed infection with hepatitis B virus (HBsAg positive), hepatitis C virus (anti-HCV positive) or human immunodeficiency virus (HIV positive) at screening.
• History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed).
• Known bleeding disorders.
• Women who are pregnant, breast-feeding, or considering becoming pregnant.
• Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant.