Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2019-03-22
2019-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
Study Groups
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Cohort 1 (Initial Safety Cohort) 1 mg/kg
4 participants will be administered Dengushield at 1 mg/kg body weight as Intravenous injection.
Dengushield 1 mg/kg (Cohort 1) intravenous
Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
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.
Dengushield 3 mg/kg (Cohort 2) intravenous
Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
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.
Placebo 3 mg/kg (Cohort 2) intravenous
Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
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.
Dengushield 7 mg/kg (Cohort 3) intravenous
Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
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.
Placebo 7 mg/kg (Cohort 3) intravenous
Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
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.
Dengushield 12 mg/kg (Cohort 4) intravenous
Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
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.
Placebo 12 mg/kg (Cohort 4) intravenous
Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.
Interventions
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Dengushield 1 mg/kg (Cohort 1) intravenous
Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
Dengushield 3 mg/kg (Cohort 2) intravenous
Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
Placebo 3 mg/kg (Cohort 2) intravenous
Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
Dengushield 7 mg/kg (Cohort 3) intravenous
Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
Placebo 7 mg/kg (Cohort 3) intravenous
Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
Dengushield 12 mg/kg (Cohort 4) intravenous
Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
Placebo 12 mg/kg (Cohort 4) intravenous
Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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PPD Development, LP
INDUSTRY
Serum Institute of India Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Prasad Kulkarni, MD
Role: STUDY_DIRECTOR
Serum Institute of India Pvt. Ltd.
Locations
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CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
Countries
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References
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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.
Other Identifiers
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Dengushield-01
Identifier Type: -
Identifier Source: org_study_id
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