Safety Study of Dengushield in Healthy Adults
Study Details
Study Description
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
Primary Outcome Measures
- 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 [4 hours post administration of drug]
Safety monitoring for 4 hours
- The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs) [84 days]
Safety
- Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings [28 days]
Safety
Secondary Outcome Measures
- Time to maximum serum concentration of Dengushield - Tmax [84 days]
Time to maximum serum concentration of Dengushield - Tmax
- Presence or absence of anti-Dengushield antibody in sera samples [84 days]
Anti-Dengushield antibodies will be checked in sera samples.
- Maximum serum concentration of dengushield - Cmax [84 days]
Maximum serum concentration of dengushield
- AUC from time 0 to infinity of Dengushield [84 days]
Area under curve of Dengushield from time 0 to infinity (AUC0-infinity)
- AUC from time 0 to 84 days of Dengushield [84 days]
Area under curve of Dengushield from time 0 to 84 days (AUC0-84d)
- Half life of Dengushield - t1/2 [84 days]
Half life of Dengushield
- Volume of distribution of Dengushield [84 days]
Volume of distribution of Dengushield
- Clearance of dengushield [84 days]
Clearance of dengushield
- Elimination rate constant of dengushield [84 days]
Elimination rate constant of dengushield
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults aged 18-45 years, men, or women.
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Negative Dengue NS1 at screening indicating no current dengue infection
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Seronegative for dengue IgG
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Participants who are willing to comply with the requirements of the study protocol and attend scheduled visit.
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Participants who give written informed consent.
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Participants having laboratory parameters within normal range
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Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
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Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that is acceptable for study entry.
Exclusion Criteria:
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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
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History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
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Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
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Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
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Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
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Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing except for influenza vaccination.
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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.
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Laboratory confirmed infection with hepatitis B virus (HBsAg positive), hepatitis C virus (anti-HCV positive) or human immunodeficiency virus (HIV positive) at screening.
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History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed).
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Known bleeding disorders.
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Women who are pregnant, breast-feeding, or considering becoming pregnant.
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Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CMAX Clinical Research Pty Ltd | Adelaide | South Australia | Australia | 5000 |
Sponsors and Collaborators
- Serum Institute of India Pvt. Ltd.
- PPD
Investigators
- Study Director: Prasad Kulkarni, MD, Serum Institute of India Pvt. Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dengushield-01