This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
The proportion of participants with post-injection/ infusion adverse events (AEs) including hypersensitivity reaction, anaphylactic reaction and other AEs occurring within 4 hours of the start of dosing
Safety monitoring for 4 hours
Time frame: 4 hours post administration of drug
The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)
Safety
Time frame: 84 days
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Safety
Time frame: 28 days
Time to maximum serum concentration of Dengushield - Tmax
Time to maximum serum concentration of Dengushield - Tmax
Time frame: 84 days
Presence or absence of anti-Dengushield antibody in sera samples
Anti-Dengushield antibodies will be checked in sera samples.
Time frame: 84 days
Maximum serum concentration of dengushield - Cmax
Maximum serum concentration of dengushield
Time frame: 84 days
AUC from time 0 to infinity of Dengushield
Area under curve of Dengushield from time 0 to infinity (AUC0-infinity)
Time frame: 84 days
AUC from time 0 to 84 days of Dengushield
Area under curve of Dengushield from time 0 to 84 days (AUC0-84d)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.
Time frame: 84 days
Half life of Dengushield - t1/2
Half life of Dengushield
Time frame: 84 days
Volume of distribution of Dengushield
Volume of distribution of Dengushield
Time frame: 84 days
Clearance of dengushield
Clearance of dengushield
Time frame: 84 days
Elimination rate constant of dengushield
Elimination rate constant of dengushield
Time frame: 84 days