Safety Study of Dengushield in Healthy Adults

A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults

Sponsors

Lead Sponsor: Serum Institute of India Pvt. Ltd.

Collaborator: PPD

Source Serum Institute of India Pvt. Ltd.
Brief Summary

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

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.

Overall Status Completed
Start Date 2019-03-22
Completion Date 2019-12-23
Primary Completion Date 2019-12-23
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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
The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs) 84 days
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings 28 days
Secondary Outcome
Measure Time Frame
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
Half life of Dengushield - t1/2 84 days
Volume of distribution of Dengushield 84 days
Clearance of dengushield 84 days
Elimination rate constant of dengushield 84 days
Enrollment 40
Condition
Intervention

Intervention Type: Biological

Intervention Name: Dengushield 1 mg/kg (Cohort 1) intravenous

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

Arm Group Label: Cohort 1 (Initial Safety Cohort) 1 mg/kg

Intervention Type: Biological

Intervention Name: Dengushield 3 mg/kg (Cohort 2) intravenous

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

Arm Group Label: Cohort 2 Experimental 3mg/kg

Intervention Type: Biological

Intervention Name: Placebo 3 mg/kg (Cohort 2) intravenous

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

Arm Group Label: Cohort 2 Placebo 3 mg/kg

Intervention Type: Biological

Intervention Name: Dengushield 7 mg/kg (Cohort 3) intravenous

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

Arm Group Label: Cohort 3 Experimental 7 mg/kg

Intervention Type: Biological

Intervention Name: Placebo 7 mg/kg (Cohort 3) intravenous

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

Arm Group Label: Cohort 3 Placebo 7 mg/kg

Intervention Type: Biological

Intervention Name: Dengushield 12 mg/kg (Cohort 4) intravenous

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

Arm Group Label: Cohort 4 Experimental 12 mg/kg

Intervention Type: Biological

Intervention Name: Placebo 12 mg/kg (Cohort 4) intravenous

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

Arm Group Label: Cohort 4 Placebo 12 mg/kg

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Prasad Kulkarni, MD Study Director Serum Institute of India Pvt. Ltd.
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: CMAX Clinical Research Pty Ltd
Location Countries

Australia

Verification Date

2020-02-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 7
Arm Group

Label: Cohort 1 (Initial Safety Cohort) 1 mg/kg

Type: Experimental

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

Label: Cohort 2 Experimental 3mg/kg

Type: Experimental

Description: 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.

Label: Cohort 2 Placebo 3 mg/kg

Type: Placebo Comparator

Description: 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.

Label: Cohort 3 Experimental 7 mg/kg

Type: Experimental

Description: 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.

Label: Cohort 3 Placebo 7 mg/kg

Type: Placebo Comparator

Description: 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.

Label: Cohort 4 Experimental 12 mg/kg

Type: Experimental

Description: 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.

Label: Cohort 4 Placebo 12 mg/kg

Type: Placebo Comparator

Description: 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.

Patient Data No
Study Design Info

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.

Primary Purpose: Treatment

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.

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