Safety Study of Dengushield in Healthy Adults

Serum Institute of India

Status and phase: Completed; Phase 1

Conditions: Dengue; Phase 1

Treatments: Biological: Dengushield 12 mg/kg (Cohort 4) intravenous; Biological: Dengushield 3 mg/kg (Cohort 2) intravenous; Biological: Placebo 7 mg/kg (Cohort 3) intravenous; Biological: Placebo 3 mg/kg (Cohort 2) intravenous; Biological: Dengushield 7 mg/kg (Cohort 3) intravenous; Biological: Placebo 12 mg/kg (Cohort 4) intravenous; Biological: Dengushield 1 mg/kg (Cohort 1) intravenous

Study type: Interventional

Funder types: Industry

Identifiers

NCT03883620

Dengushield-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 7 patient groups, including a placebo group

Cohort 1 (Initial Safety Cohort) 1 mg/kg

Experimental group

Description:

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

Treatment:

Biological: Dengushield 1 mg/kg (Cohort 1) intravenous

Cohort 2 Experimental 3mg/kg

Experimental group

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.

Treatment:

Biological: Dengushield 3 mg/kg (Cohort 2) intravenous

Cohort 2 Placebo 3 mg/kg

Placebo Comparator group

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.

Treatment:

Biological: Placebo 3 mg/kg (Cohort 2) intravenous

Cohort 3 Experimental 7 mg/kg

Experimental group

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.

Treatment:

Biological: Dengushield 7 mg/kg (Cohort 3) intravenous

Cohort 3 Placebo 7 mg/kg

Placebo Comparator group

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.

Treatment:

Biological: Placebo 7 mg/kg (Cohort 3) intravenous

Cohort 4 Experimental 12 mg/kg

Experimental group

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.

Treatment:

Biological: Dengushield 12 mg/kg (Cohort 4) intravenous

Cohort 4 Placebo 12 mg/kg

Placebo Comparator group

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.

Treatment:

Biological: Placebo 12 mg/kg (Cohort 4) intravenous