Safety Study of Dengushield in Healthy Adults

Dengue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883620
• Other study ID #: Dengushield-01
• Status: Completed
• Phase: Phase 1
• Start date: March 22, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: February 2020
• Source: Serum Institute of India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dengue
• Phase 1

Intervention

Biological:
• Dengushield 1 mg/kg (Cohort 1) intravenous
Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
• Dengushield 3 mg/kg (Cohort 2) intravenous
Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
• Placebo 3 mg/kg (Cohort 2) intravenous
Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
• Dengushield 7 mg/kg (Cohort 3) intravenous
Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
• Placebo 7 mg/kg (Cohort 3) intravenous
Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
• Dengushield 12 mg/kg (Cohort 4) intravenous
Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
• Placebo 12 mg/kg (Cohort 4) intravenous
Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.

Locations

Country	Name	City	State
Australia	CMAX Clinical Research Pty Ltd	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Serum Institute of India Pvt. Ltd.	PPD

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety monitoring for 4 hours	4 hours post administration of drug
Primary	The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)	Safety	84 days
Primary	Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings	Safety	28 days
Secondary	Time to maximum serum concentration of Dengushield - Tmax	Time to maximum serum concentration of Dengushield - Tmax	84 days
Secondary	Presence or absence of anti-Dengushield antibody in sera samples	Anti-Dengushield antibodies will be checked in sera samples.	84 days
Secondary	Maximum serum concentration of dengushield - Cmax	Maximum serum concentration of dengushield	84 days
Secondary	AUC from time 0 to infinity of Dengushield	Area under curve of Dengushield from time 0 to infinity (AUC0-infinity)	84 days
Secondary	AUC from time 0 to 84 days of Dengushield	Area under curve of Dengushield from time 0 to 84 days (AUC0-84d)	84 days
Secondary	Half life of Dengushield - t1/2	Half life of Dengushield	84 days
Secondary	Volume of distribution of Dengushield	Volume of distribution of Dengushield	84 days
Secondary	Clearance of dengushield	Clearance of dengushield	84 days
Secondary	Elimination rate constant of dengushield	Elimination rate constant of dengushield	84 days