Safety Study of Dengushield in Healthy Adults

Summary

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

Conditions

• Phase 1
• Dengue

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.

Sponsors & Collaborators

• PPD Development, LP

  collaborator INDUSTRY

• Serum Institute of India Pvt. Ltd.

  lead INDUSTRY

Principal Investigators

• Prasad Kulkarni, MD · Serum Institute of India Pvt. Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-22

Primary Completion

2019-12-23

Completion

2019-12-23

Countries

• Australia

Study Locations