Safety Study of Dengushield in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 22, 2019

Primary Completion Date

December 23, 2019

Study Completion Date

December 23, 2019

Conditions
Phase 1Dengue
Interventions
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.

Trial Locations (1)

5000

CMAX Clinical Research Pty Ltd, Adelaide

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Serum Institute of India Pvt. Ltd.

INDUSTRY