CompletedNCT03883620Updated Feb 18, 2020

Safety Study of Dengushield in Healthy Adults

A Phase 1 interventional study of Dengushield 1 mg/kg (Cohort 1) intravenous and Dengushield 3 mg/kg (Cohort 2) intravenous in Phase 1 and Dengue, sponsored by Serum Institute of India Pvt. Ltd.. Completed at 1 site in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by Serum Institute of India Pvt. Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

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

Read the 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 studied

Phase 1
Dengue

Browse trials for

Dengue 279

Keywords

Dengue

In context

Dengue

279 studies on the registry are indexed under Dengue; 45 are open to participants now.

This study's enrollment of 40 is below the median of 123 across 195 interventional studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Serum Institute of India Pvt. Ltd. is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

Experimental
Cohort 1 (Initial Safety Cohort) 1 mg/kg
4 participants will be administered Dengushield at 1 mg/kg body weight as Intravenous injection.
Biological: Dengushield 1 mg/kg (Cohort 1) intravenous
Experimental
Cohort 2 Experimental 3mg/kg
Initially two participants will be randomized in 1:1 ratio to Dengushield or placebo as a sentinel cohort. If there are no causally related serious safety findings, remaining 10 participants for that cohort will be randomized in 9:1 ratio to Dengushield or placebo.
Biological: Dengushield 3 mg/kg (Cohort 2) intravenous
Placebo comparator
Cohort 2 Placebo 3 mg/kg
Initially two participants will be randomized in 1:1 ratio to Dengushield or placebo as a sentinel cohort. If there are no causally related serious safety findings, remaining 10 participants for that cohort will be randomized in 9:1 ratio to Dengushield or placebo and enrolled.
Biological: Placebo 3 mg/kg (Cohort 2) intravenous
Experimental
Cohort 3 Experimental 7 mg/kg
Initially two participants will be randomized in 1:1 ratio to Dengushield or placebo as a sentinel cohort. If there are no causally related serious safety findings, remaining 10 participants for that cohort will be randomized in 9:1 ratio to Dengushield or placebo.
Biological: Dengushield 7 mg/kg (Cohort 3) intravenous
Placebo comparator
Cohort 3 Placebo 7 mg/kg
Initially two participants will be randomized in 1:1 ratio to Dengushield or placebo as a sentinel cohort. If there are no causally related serious safety findings, remaining 10 participants for that cohort will be randomized in 9:1 ratio to Dengushield or placebo.
Biological: Placebo 7 mg/kg (Cohort 3) intravenous
Experimental
Cohort 4 Experimental 12 mg/kg
Initially two participants will be randomized in 1:1 ratio to Dengushield or placebo as a sentinel cohort. If there are no causally related serious safety findings, remaining 10 participants for that cohort will be randomized in 9:1 ratio to Dengushield or placebo.
Biological: Dengushield 12 mg/kg (Cohort 4) intravenous
Placebo comparator
Cohort 4 Placebo 12 mg/kg
Initially two participants will be randomized in 1:1 ratio to Dengushield or placebo as a sentinel cohort. If there are no causally related serious safety findings, remaining 10 participants for that cohort will be randomized in 9:1 ratio to Dengushield or placebo.
Biological: Placebo 12 mg/kg (Cohort 4) intravenous

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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)
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

Study locations

1 site

CMAX Clinical Research Pty Ltd
Adelaide, South Australia 5000, Australia

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03883620
Lead sponsor: Serum Institute of India Pvt. Ltd.
Collaborators: PPD DEVELOPMENT, LP
Responsible party: Sponsor
First posted: Mar 21, 2019
Start date: Mar 22, 2019
Primary completion: Dec 23, 2019
Completion: Dec 23, 2019
Last update: Feb 18, 2020

Study contacts

Prasad Kulkarni, MD

study director · Serum Institute of India Pvt. Ltd.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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