Clinical trial NCT03883620: Safety Study of Dengushield in Healthy Adults
Official title: A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Phase 1
Dengue
Keywords: Dengue
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2019-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: 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
timeFrame: 4 hours post administration of drug
measure: The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)
timeFrame: 84 days
measure: Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
timeFrame: 28 days
Secondary outcomes:
measure: Time to maximum serum concentration of Dengushield - Tmax
timeFrame: 84 days
measure: Presence or absence of anti-Dengushield antibody in sera samples
timeFrame: 84 days
measure: Maximum serum concentration of dengushield - Cmax
timeFrame: 84 days
measure: AUC from time 0 to infinity of Dengushield
timeFrame: 84 days
measure: AUC from time 0 to 84 days of Dengushield
timeFrame: 84 days
measure: Half life of Dengushield - t1/2
timeFrame: 84 days
measure: Volume of distribution of Dengushield
timeFrame: 84 days
measure: Clearance of dengushield
timeFrame: 84 days
measure: Elimination rate constant of dengushield
timeFrame: 84 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research Pty Ltd
state: South Australia
Study officials:
affiliation: Serum Institute of India Pvt. Ltd.
name: Prasad Kulkarni, MD
role: STUDY_DIRECTOR
References: