NCT03883620

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 22, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

March 16, 2019

Last Update Submit

February 15, 2020

Conditions

Phase 1Dengue

Keywords

Dengue

Outcome Measures

Primary Outcomes (3)

  • 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

    4 hours post administration of drug

  • The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)

    Safety

    84 days

  • Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings

    Safety

    28 days

Secondary Outcomes (9)

  • Time to maximum serum concentration of Dengushield - Tmax

    84 days

  • Presence or absence of anti-Dengushield antibody in sera samples

    84 days

  • Maximum serum concentration of dengushield - Cmax

    84 days

  • AUC from time 0 to infinity of Dengushield

    84 days

  • AUC from time 0 to 84 days of Dengushield

    84 days

  • +4 more secondary outcomes

Study Arms (7)

Cohort 1 (Initial Safety Cohort) 1 mg/kg

EXPERIMENTAL

4 participants will be administered Dengushield at 1 mg/kg body weight as Intravenous injection.

Biological: Dengushield 1 mg/kg (Cohort 1) intravenous

Cohort 2 Experimental 3mg/kg

EXPERIMENTAL

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

Cohort 2 Placebo 3 mg/kg

PLACEBO COMPARATOR

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

Cohort 3 Experimental 7 mg/kg

EXPERIMENTAL

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

Cohort 3 Placebo 7 mg/kg

PLACEBO COMPARATOR

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

Cohort 4 Experimental 12 mg/kg

EXPERIMENTAL

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

Cohort 4 Placebo 12 mg/kg

PLACEBO COMPARATOR

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

Dengushield 1 mg/kg (Cohort 1) intravenousBIOLOGICAL

Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.

Cohort 1 (Initial Safety Cohort) 1 mg/kg
Dengushield 3 mg/kg (Cohort 2) intravenousBIOLOGICAL

Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.

Cohort 2 Experimental 3mg/kg
Placebo 3 mg/kg (Cohort 2) intravenousBIOLOGICAL

Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.

Cohort 2 Placebo 3 mg/kg
Dengushield 7 mg/kg (Cohort 3) intravenousBIOLOGICAL

Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.

Cohort 3 Experimental 7 mg/kg
Placebo 7 mg/kg (Cohort 3) intravenousBIOLOGICAL

Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.

Cohort 3 Placebo 7 mg/kg
Dengushield 12 mg/kg (Cohort 4) intravenousBIOLOGICAL

Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.

Cohort 4 Experimental 12 mg/kg
Placebo 12 mg/kg (Cohort 4) intravenousBIOLOGICAL

Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.

Cohort 4 Placebo 12 mg/kg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

  • Gunale B, Farinola N, Kamat CD, Poonawalla CS, Pisal SS, Dhere RM, Miller C, Kulkarni PS. An observer-blind, randomised, placebo-controlled, phase 1, single ascending dose study of dengue monoclonal antibody in healthy adults in Australia. Lancet Infect Dis. 2024 Jun;24(6):639-649. doi: 10.1016/S1473-3099(24)00030-6. Epub 2024 Feb 23.

    PMID: 38408457DERIVED

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Prasad Kulkarni, MD

    Serum Institute of India Pvt. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
For the Cohort 1 (Initial Safety Cohort), no placebo control will be used and hence, blinding is not applicable.For remaining cohorts, both participant and investigator will be unaware of treatment allocation as well as the laboratories analyzing the biochemistry and hematology parameters, pharmacokinetic and immunogenicity (ADA) samples will be blinded to treatment allocation. The drug administrator will be unblinded who will prepare and administer the study drugs. The 7 day safety data for each cohort will be reviewed by group-wise unblinding. Individual level unblinding will be done only in cases of suspected serious adverse reactions as per the judgement of investigator or medical monitor / sponsor representative.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a Phase 1, randomized, partially-blind (observer-blind), placebo controlled, single dose ascending study in healthy adults. For the Cohort 1 (Initial Safety Cohort), no placebo control will be used and hence, blinding is not applicable. There will be 4 dose levels. The proposed doses to be studied are; 1 mg/kg, 3 mg/kg, 12 mg/kg and 25 mg/kg. Total of 40 participants will be dosed and followed till Day 84 from dosing.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2019

First Posted

March 21, 2019

Study Start

March 22, 2019

Primary Completion

December 23, 2019

Study Completion

December 23, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)