Phase 1Phase 1NCT03883620
Safety Study of Dengushield in Healthy Adults
A Phase 1 study testing Dengushield 1 mg/kg (Cohort 1) intravenous, Dengushield 3 mg/kg (Cohort 2) intravenous and Dengushield 7 mg/kg (Cohort 3) intravenous in people with Phase 1 and Dengue, run by Serum Institute of India Pvt. Ltd. at 1 site in Australia.
Trial summary
This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Dengushield 1 mg/kg (Cohort 1) intravenous, Dengushield 3 mg/kg (Cohort 2) intravenous and Dengushield 7 mg/kg (Cohort 3) intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Mar 2019to 23 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-45 years, men, or women.
- Negative Dengue NS1 at screening indicating no current dengue infection
- Seronegative for dengue IgG
- Participants who are willing to comply with the requirements of the study protocol and attend scheduled visit.
- Participants who give written informed consent.
- Participants having laboratory parameters within normal range
- Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
- Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that is acceptable for study entry.
Who cannot join
- 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
- History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
- Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
- Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
- Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
- Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing except for influenza vaccination.
Show all 12Show fewer
- 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.
- Laboratory confirmed infection with hepatitis B virus (HBsAg positive), hepatitis C virus (anti-HCV positive) or human immunodeficiency virus (HIV positive) at screening.
- History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed).
- Known bleeding disorders.
- Women who are pregnant, breast-feeding, or considering becoming pregnant.
- Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults
This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults.
Read the 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.
- Being tested
- Dengushield 1 mg/kg (Cohort 1) intravenous, Dengushield 3 mg/kg (Cohort 2) intravenous, Placebo 3 mg/kg (Cohort 2) intravenous, Dengushield 7 mg/kg (Cohort 3) intravenous, Placebo 7 mg/kg (Cohort 3) intravenous
- Keywords
- Dengue
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengushield 1 mg/kg (Cohort 1) intravenousBiological
Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
Dengushield 3 mg/kg (Cohort 2) intravenousBiological
Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
Placebo 3 mg/kg (Cohort 2) intravenousBiological
Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
Dengushield 7 mg/kg (Cohort 3) intravenousBiological
Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
Placebo 7 mg/kg (Cohort 3) intravenousBiological
Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
Dengushield 12 mg/kg (Cohort 4) intravenousBiological
Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
Placebo 12 mg/kg (Cohort 4) intravenousBiological
Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Initial Safety Cohort) 1 mg/kg | Experimental | 4 participants will be administered Dengushield at 1 mg/kg body weight as Intravenous injection. Receives: Biological: Dengushield 1 mg/kg (Cohort 1) intravenous |
| Cohort 2 Experimental 3mg/kg | Experimental | 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. Receives: Biological: Dengushield 3 mg/kg (Cohort 2) intravenous |
| Cohort 2 Placebo 3 mg/kg | Placebo comparator | 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. Receives: Biological: Placebo 3 mg/kg (Cohort 2) intravenous |
| Cohort 3 Experimental 7 mg/kg | Experimental | 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. Receives: Biological: Dengushield 7 mg/kg (Cohort 3) intravenous |
| Cohort 3 Placebo 7 mg/kg | Placebo comparator | 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. Receives: Biological: Placebo 7 mg/kg (Cohort 3) intravenous |
| Cohort 4 Experimental 12 mg/kg | Experimental | 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. Receives: Biological: Dengushield 12 mg/kg (Cohort 4) intravenous |
| Cohort 4 Placebo 12 mg/kg | Placebo comparator | 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. Receives: Biological: Placebo 12 mg/kg (Cohort 4) intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours post administration of drug
The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)
Safety
Measured: 84 days
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Safety
Measured: 28 days
Secondary outcomes (9)
Time to maximum serum concentration of Dengushield - Tmax
Time to maximum serum concentration of Dengushield - Tmax
Measured: 84 days
Presence or absence of anti-Dengushield antibody in sera samples
Anti-Dengushield antibodies will be checked in sera samples.
Measured: 84 days
Maximum serum concentration of dengushield - Cmax
Maximum serum concentration of dengushield
Measured: 84 days
AUC from time 0 to infinity of Dengushield
Area under curve of Dengushield from time 0 to infinity (AUC0-infinity)
Measured: 84 days
AUC from time 0 to 84 days of Dengushield
Area under curve of Dengushield from time 0 to 84 days (AUC0-84d)
Measured: 84 days
Half life of Dengushield - t1/2
Half life of Dengushield
Measured: 84 days
Volume of distribution of Dengushield
Volume of distribution of Dengushield
Measured: 84 days
Clearance of dengushield
Clearance of dengushield
Measured: 84 days
Elimination rate constant of dengushield
Elimination rate constant of dengushield
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start22 Mar 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phase 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Prasad Kulkarni, MD, Study director, Serum Institute of India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883620
- Sponsor's protocol ID
- Dengushield-01
- Status last verified
- Feb 2020
- First submitted
- 16 Mar 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunale B, Farinola N, Kamat CD, Poonawalla CS, Pisal SS, Dhere RM, Miller C, Kulkarni PS. An observer-blind, randomised, placebo-controlled, phase 1, single ascending dose study of dengue monoclonal antibody in healthy adults in Australia. Lancet Infect Dis. 2024 Jun;24(6):639-649. doi: 10.1016/S1473-3099(24)00030-6. Epub 2024 Feb 23.
PubMed 38408457
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Partially Blind (Observer-blind), Randomized, Single Dose Ascending Study of Dengue Monoclonal Antibody (Dengushield) in Healthy Adults
- ClinicalTrials.gov ID
- NCT03883620
- Acronym / sponsor ID
- Dengushield-01
- Keywords
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Initial Safety Cohort) 1 mg/kg | Experimental | Biological: Dengushield 1 mg/kg (Cohort 1) intravenous4 participants will be administered Dengushield at 1 mg/kg body weight as Intravenous injection. |
| Cohort 2 Experimental 3mg/kg | Experimental | Biological: Dengushield 3 mg/kg (Cohort 2) intravenousInitially 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. |
| Cohort 2 Placebo 3 mg/kg | Placebo comparator | Biological: Placebo 3 mg/kg (Cohort 2) intravenousInitially 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. |
| Cohort 3 Experimental 7 mg/kg | Experimental | Biological: Dengushield 7 mg/kg (Cohort 3) intravenousInitially 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. |
| Cohort 3 Placebo 7 mg/kg | Placebo comparator | Biological: Placebo 7 mg/kg (Cohort 3) intravenousInitially 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. |
| Cohort 4 Experimental 12 mg/kg | Experimental | Biological: Dengushield 12 mg/kg (Cohort 4) intravenousInitially 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. |
| Cohort 4 Placebo 12 mg/kg | Placebo comparator | Biological: Placebo 12 mg/kg (Cohort 4) intravenousInitially 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults aged 18-45 years, men, or women.
- Negative Dengue NS1 at screening indicating no current dengue infection
- Seronegative for dengue IgG
- Participants who are willing to comply with the requirements of the study protocol and attend scheduled visit.
- Participants who give written informed consent.
Key exclusion criteria (12 listed)
- 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
- History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
- Evidence of any other significant active haematological disease, or having donated > 450 mL of blood within the past three months.
- Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
- Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dengushield 1 mg/kg (Cohort 1) intravenousParticipants will be administered Dengushield 1 mg/kg as slow intravenous injection. | Biological | Cohort 1 (Initial Safety Cohort) 1 mg/kg |
| Dengushield 3 mg/kg (Cohort 2) intravenousParticipants will be administered Dengushield 3 mg/kg as slow intravenous infusion. | Biological | Cohort 2 Experimental 3mg/kg |
| Placebo 3 mg/kg (Cohort 2) intravenousParticipants will be administered Placebo 3 mg/kg as slow intravenous infusion. | Biological | Cohort 2 Placebo 3 mg/kg |
| Dengushield 7 mg/kg (Cohort 3) intravenousParticipants will be administered Dengushield 7 mg/kg as slow intravenous infusion. | Biological | Cohort 3 Experimental 7 mg/kg |
| Placebo 7 mg/kg (Cohort 3) intravenousParticipants will be administered Placebo 7 mg/kg as slow intravenous infusion. | Biological | Cohort 3 Placebo 7 mg/kg |
| Dengushield 12 mg/kg (Cohort 4) intravenousParticipants will be administered Dengushield 12 mg/kg as slow intravenous infusion. | Biological | Cohort 4 Experimental 12 mg/kg |
| Placebo 12 mg/kg (Cohort 4) intravenousParticipants will be administered Placebo 12 mg/kg as slow intravenous infusion. | Biological | Cohort 4 Placebo 12 mg/kg |
Primary outcome
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
Time frame: 4 hours post administration of drug
Safety monitoring for 4 hours
The proportion of participants with AEs, discontinuations due to AEs, and serious adverse events (SAEs)
Time frame: 84 days
Safety
Proportion of participants with clinically significant abnormal safety laboratory (hematology and chemistry parameters) findings
Time frame: 28 days
Safety
9 secondary outcomes
Time to maximum serum concentration of Dengushield - Tmax
Time frame: 84 days
Presence or absence of anti-Dengushield antibody in sera samples
Time frame: 84 days
Maximum serum concentration of dengushield - Cmax
Time frame: 84 days
AUC from time 0 to infinity of Dengushield
Time frame: 84 days
AUC from time 0 to 84 days of Dengushield
Time frame: 84 days
Half life of Dengushield - t1/2
Time frame: 84 days
Volume of distribution of Dengushield
Time frame: 84 days
Clearance of dengushield
Time frame: 84 days
Elimination rate constant of dengushield
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 38408457Gunale B, Farinola N, Kamat CD, Poonawalla CS, Pisal SS, Dhere RM, Miller C, Kulkarni PS. An observer-blind, randomised, placebo-controlled, phase 1, single ascending dose study of dengue monoclonal antibody in healthy adults in Australia. Lancet Infect Dis. 2024 Jun;24(6):639-649. doi: 10.1016/S1473-3099(24)00030-6. Epub 2024 Feb 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasad Kulkarni, MD study director
Serum Institute of India Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dengushield 1 mg/kg (Cohort 1) intravenous, Dengushield 3 mg/kg (Cohort 2) intravenous and Dengushield 7 mg/kg (Cohort 3) intravenous in people with Phase 1 and Dengue, run by Serum Institute of India Pvt. Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 4 hours post administration of drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.