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Safety Study of Dengushield in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883620
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Serum Institute of India Pvt. Ltd.

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

Condition or disease Intervention/treatment Phase
Phase 1 Dengue Biological: Dengushield 1 mg/kg (Cohort 1) intravenous Biological: Dengushield 3 mg/kg (Cohort 2) intravenous Biological: Placebo 3 mg/kg (Cohort 2) intravenous Biological: Dengushield 7 mg/kg (Cohort 3) intravenous Biological: Placebo 7 mg/kg (Cohort 3) intravenous Biological: Dengushield 12 mg/kg (Cohort 4) intravenous Biological: Placebo 12 mg/kg (Cohort 4) intravenous Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arms and Interventions
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Arm Intervention/treatment
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
Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
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
Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
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
Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
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
Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
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
Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
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
Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
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
Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 4 hours post administration of drug ]
    Safety monitoring for 4 hours

  2. The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs) [ Time Frame: 84 days ]
    Safety

  3. Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings [ Time Frame: 28 days ]
    Safety


Secondary Outcome Measures :
  1. Time to maximum serum concentration of Dengushield - Tmax [ Time Frame: 84 days ]
    Time to maximum serum concentration of Dengushield - Tmax

  2. Presence or absence of anti-Dengushield antibody in sera samples [ Time Frame: 84 days ]
    Anti-Dengushield antibodies will be checked in sera samples.

  3. Maximum serum concentration of dengushield - Cmax [ Time Frame: 84 days ]
    Maximum serum concentration of dengushield

  4. AUC from time 0 to infinity of Dengushield [ Time Frame: 84 days ]
    Area under curve of Dengushield from time 0 to infinity (AUC0-infinity)

  5. AUC from time 0 to 84 days of Dengushield [ Time Frame: 84 days ]
    Area under curve of Dengushield from time 0 to 84 days (AUC0-84d)

  6. Half life of Dengushield - t1/2 [ Time Frame: 84 days ]
    Half life of Dengushield

  7. Volume of distribution of Dengushield [ Time Frame: 84 days ]
    Volume of distribution of Dengushield

  8. Clearance of dengushield [ Time Frame: 84 days ]
    Clearance of dengushield

  9. Elimination rate constant of dengushield [ Time Frame: 84 days ]
    Elimination rate constant of dengushield


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adults aged 18-45 years, men, or women.
  2. Negative Dengue NS1 at screening indicating no current dengue infection
  3. Seronegative for dengue IgG
  4. Participants who are willing to comply with the requirements of the study protocol and attend scheduled visit.
  5. Participants who give written informed consent.
  6. Participants having laboratory parameters within normal range
  7. Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
  8. Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that is acceptable for study entry.

Exclusion Criteria:

  1. 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
  2. History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
  3. Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
  4. Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
  5. Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
  6. Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing except for influenza vaccination.
  7. 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.
  8. Laboratory confirmed infection with hepatitis B virus (HBsAg positive), hepatitis C virus (anti-HCV positive) or human immunodeficiency virus (HIV positive) at screening.
  9. History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed).
  10. Known bleeding disorders.
  11. Women who are pregnant, breast-feeding, or considering becoming pregnant.
  12. Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883620


Locations
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Australia, South Australia
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Serum Institute of India Pvt. Ltd.
PPD
Investigators
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Study Director: Prasad Kulkarni, MD Serum Institute of India Pvt. Ltd.
More Information
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Responsible Party: Serum Institute of India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03883620    
Other Study ID Numbers: Dengushield-01
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Serum Institute of India Pvt. Ltd.:
Dengue
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral