NCT03883620

Safety Study of Dengushield in Healthy Adults

A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults.

Detailed description

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.

Conditions

• Phase 1
• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	Dengushield 1 mg/kg (Cohort 1) intravenous	Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
BIOLOGICAL	Dengushield 3 mg/kg (Cohort 2) intravenous	Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
BIOLOGICAL	Placebo 3 mg/kg (Cohort 2) intravenous	Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
BIOLOGICAL	Dengushield 7 mg/kg (Cohort 3) intravenous	Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
BIOLOGICAL	Placebo 7 mg/kg (Cohort 3) intravenous	Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
BIOLOGICAL	Dengushield 12 mg/kg (Cohort 4) intravenous	Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
BIOLOGICAL	Placebo 12 mg/kg (Cohort 4) intravenous	Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.

Timeline

• Start date: 2019-03-22
• Primary completion: 2019-12-23
• Completion: 2019-12-23
• First posted: 2019-03-21
• Last updated: 2020-02-18

Locations

1 site across 1 country: Australia