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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03883620




Registration number
NCT03883620
Ethics application status
Date submitted
16/03/2019
Date registered
21/03/2019

Titles & IDs
Public title
Safety Study of Dengushield in Healthy Adults
Scientific title
A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults
Secondary ID [1] 0 0
Dengushield-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phase 1 0 0
Dengue 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Dengushield 1 mg/kg (Cohort 1) intravenous
Treatment: Other - Dengushield 3 mg/kg (Cohort 2) intravenous
Treatment: Other - Placebo 3 mg/kg (Cohort 2) intravenous
Treatment: Other - Dengushield 7 mg/kg (Cohort 3) intravenous
Treatment: Other - Placebo 7 mg/kg (Cohort 3) intravenous
Treatment: Other - Dengushield 12 mg/kg (Cohort 4) intravenous
Treatment: Other - Placebo 12 mg/kg (Cohort 4) intravenous

Experimental: Cohort 1 (Initial Safety Cohort) 1 mg/kg - 4 participants will be administered Dengushield at 1 mg/kg body weight as 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.

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.

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.

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.

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.

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.


Treatment: Other: Dengushield 1 mg/kg (Cohort 1) intravenous
Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.

Treatment: Other: Dengushield 3 mg/kg (Cohort 2) intravenous
Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.

Treatment: Other: Placebo 3 mg/kg (Cohort 2) intravenous
Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.

Treatment: Other: Dengushield 7 mg/kg (Cohort 3) intravenous
Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.

Treatment: Other: Placebo 7 mg/kg (Cohort 3) intravenous
Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.

Treatment: Other: Dengushield 12 mg/kg (Cohort 4) intravenous
Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.

Treatment: Other: Placebo 12 mg/kg (Cohort 4) intravenous
Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
4 hours post administration of drug
Primary outcome [2] 0 0
The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)
Timepoint [2] 0 0
84 days
Primary outcome [3] 0 0
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Timepoint [3] 0 0
28 days
Secondary outcome [1] 0 0
Time to maximum serum concentration of Dengushield - Tmax
Timepoint [1] 0 0
84 days
Secondary outcome [2] 0 0
Presence or absence of anti-Dengushield antibody in sera samples
Timepoint [2] 0 0
84 days
Secondary outcome [3] 0 0
Maximum serum concentration of dengushield - Cmax
Timepoint [3] 0 0
84 days
Secondary outcome [4] 0 0
AUC from time 0 to infinity of Dengushield
Timepoint [4] 0 0
84 days
Secondary outcome [5] 0 0
AUC from time 0 to 84 days of Dengushield
Timepoint [5] 0 0
84 days
Secondary outcome [6] 0 0
Half life of Dengushield - t1/2
Timepoint [6] 0 0
84 days
Secondary outcome [7] 0 0
Volume of distribution of Dengushield
Timepoint [7] 0 0
84 days
Secondary outcome [8] 0 0
Clearance of dengushield
Timepoint [8] 0 0
84 days
Secondary outcome [9] 0 0
Elimination rate constant of dengushield
Timepoint [9] 0 0
84 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2019
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Serum Institute of India Pvt. Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PPD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prasad Kulkarni, MD
Address 0 0
Serum Institute of India Pvt. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03883620