Zika Virus InfectionPhase 1NCT03624946
Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)
A Phase 1 study testing Zika Virus Immune Globulin (ZIKV-IG) in people with Zika Virus Infection and Zika Virus Disease, run by Emergent BioSolutions at 1 site in Canada.
Trial summary
Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus Infection, Zika Virus Disease
- What is being tested?
- Zika Virus Immune Globulin (ZIKV-IG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2018to 6 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent voluntarily signed by subject.
- Age: 18-55 years of age.
- Blood type O+ or O-.
- Body mass index (BMI) of 18-30.
- Note: minimum body weight of 50 kg.
- For female subjects (with male partners) that are not surgically sterilized (e.g., did not undergo hysterectomy, bilateral oophorectomy or tubal ligation), use of an effective method of contraception throughout the trial including:
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- Using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to screening and willing to continue to use hormonal contraception throughout the entire trial.
- Intrauterine device (IUD) inserted at least 1 month prior to screening.
- Double barrier type of birth control measure (e.g., condoms, diaphragms, cervical sponge with spermicide).
- True abstinence.
- For female subjects who are post-menopausal, documented follicle- stimulating hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL) must be obtained. If the FSH is <40 mIU/mL, the subject must agree to use an acceptable form of contraception (see above).
- Females of childbearing potential without male sexual partners must be willing to maintain their sexual status as it is throughout the study.
- For male subjects that have not had a vasectomy, use of a condom with spermicide or true abstinence for the duration of the study. Note: female partners (that are of childbearing potential) of male study subjects (that have not had a vasectomy) should use one of the effective contraception methods (eg, hormonal contraception, IUD or barrier type). Also, male subjects must not donate sperm for the duration of the study.
- Males without female sexual partners must be willing to maintain their sexual status as it is throughout the study.
- Healthy as determined by principal investigator or a qualified designate based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening.
Who cannot join
- Use of any investigational product within the past 30 days.
- Use of any investigational product during the study.
- Individuals with blood type A, B or AB.
- Recipient of any blood product within the past 12 months.
- Plasma donation within 7 days or significant blood loss or blood donation within 56 days of baseline.
- Blood donation at any time during the study.
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- Females with a hemoglobin level ≤120 g/L.
- Males with a hemoglobin level <130 g/L.
- History of hypersensitivity to blood or plasma products.
- History of allergy to latex or rubber.
- History of immunoglobulin A (IgA) deficiency.
- History of hypercoagulable conditions (e.g., deep vein thrombosis or pulmonary embolism).
- History of myocardial infarction.
- History of stroke.
- History of renal impairment/failure.
- Currently pregnant or lactating or planning to become pregnant during the study.
- History of flavivirus infection [ZIKV, dengue virus (DENV), West Nile virus (WNV), Japanese encephalitis virus (JEV), yellow fever virus (YFV)] or vaccination with licensed or investigational flavivirus vaccine.
- Plans to travel to an area with active flavivirus (e.g., ZIKV and/or DENV) transmission during the study (and up to 10 months after the study drug administration) or has returned from an endemic area with these diseases within 30 days of screening.
- Positive nucleic acid test (NAT) or serology for ZIKV or positive serology for WNV or DENV.
- Positive serology test (at screening) for human immunodeficiency virus 1 and 2 (HIV), hepatitis C virus (HCV); positive test for hepatitis B virus (HBV) as determined by HBsAg.
- History of chronic or acute severe neurologic condition (e.g., diagnosis of Guillain-Barre syndrome, epilepsy, Bell's palsy, meningitis or disease with any focal neurologic deficits).
- Heavy smokers (≥15cigarettes a day) or electronic cigarette use.
- History of, or suspected substance abuse problem (including alcohol).
- Failure of drug (urine) test at screening or baseline.
- Failure of alcohol (breath) test at screening or baseline.
- Receipt of a live vaccine within 28 days prior to screening or anticipated receipt of a live vaccine during the study period.
- Individuals with planned surgical procedures that will occur during the study.
- An opinion of the investigator that it would be unwise to allow participation of the subject in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Pharmacokinetic Evaluation of Zika Virus Immune Globulin in Healthy Volunteers
Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers.
Read the detailed description
This study will be evaluating safety and pharmacokinetics (PK) of one dose level of ZIKV-IG (50 mL) in healthy adult volunteers. The study is a single-center, double-blind, randomized and placebo-controlled design. The primary objective is to assess safety of intravenously (IV) administered ZIKV-IG, while the secondary objective is to determine the PK profile of ZIKV-IG in healthy adult volunteers.
There will be a total of 30 subjects enrolled into the study; dosing of the first six subjects will be staggered over three separate days, wherein two subjects per day will be randomized 1:1 to either receive 50 mL of placebo IV or 50 mL of ZIKV-IG IV (the total amount of gamma immune globulin [IgG] protein from a single 50mL dose is 4.65g). After the first six subjects are dosed, the remaining 24 subjects will be randomized 2:1 to receive either ZIKV-IG or placebo. A safety monitoring committee will review safety data (collected up to 3 days post-dosing) of the first 12 dosed subjects prior to dosing of the remaining 18 subjects. Overall, there will be 19 subjects randomized to receive ZIKV-IG and 11 subjects randomized to receive placebo on Day 1. On Day 1 (post-dose at 1 hour, 3 hours, 8 hours) and Day 2, safety and PK assessments will be conducted while the subjects are in the Phase 1 clinic. After the discharge on Day 2, the subjects will come back to the clinic for safety and PK assessments on Days 3, 4, 6, 8, 10, 12, 15, 22, 29, 43, 57 and 85. Total study duration for each subject will be up to 4 months (from screening to Day 85).
- Conditions
- Zika Virus Infection, Zika Virus Disease
- Being tested
- Zika Virus Immune Globulin (ZIKV-IG), Placebo
- Keywords
- Zika virus, Human immune globulin, Hyperimmune, Polyclonal antibodies
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zika Virus Immune Globulin (ZIKV-IG)Biological
Also called Anti-Zika Immune Globulin (Human), NP-024
Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.
PlaceboOther
Also called Saline solution
Placebo is a normal saline solution (0.9% sodium chloride).
| Study group | Role | What they receive |
|---|---|---|
| Zika Virus Immune Globulin (ZIKV-IG) | Experimental | Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. Receives: Biological: Zika Virus Immune Globulin (ZIKV-IG) |
| Placebo (Saline Solution) | Placebo comparator | Single dose of 50 mL placebo will be administered intravenously over 33 minutes. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events.
Number of subjects with of adverse events by severity.
Measured: Up to Day 85
Secondary outcomes (7)
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Maximum Concentration (Cmax)
Maximum observed serum concentration of Zika Virus Immune Globulin (ZIKV-IG)
Measured: 0-2 hours predose to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Time to Maximum Concentration (Tmax)
Time at which maximum serum concentration of Zika Virus Immune Globulin (ZIKV-IG) occurs.
Measured: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Up to Last Quantifiable Concentration (AUC0-t)
Area under the concentration-time curve from time 0 to the last quantifiable serum Zika Virus Immune Globulin (ZIKV-IG) concentration.
Measured: 0-2 hours predose to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve from time 0 to the last quantifiable serum Zika Virus Immune Globulin (ZIKV-IG) concentration, plus the area extrapolated to infinity.
Measured: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Clearance (CL)
Total body clearance of Zika Virus Immune Globulin (ZIKV-IG) following IV administration.
Measured: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Half-Life (t1/2)
Apparent first order terminal elimination half-life of Zika Virus Immune Globulin (ZIKV-IG).
Measured: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Volume of Distribution (Vz)
Volume of distribution of Zika Virus Immune Globulin (ZIKV-IG) following IV administration.
Measured: 0-2 hours predose up to Day 85 postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start27 Jun 2018
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zika Virus InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vadim Dreyzin, MD, Principal investigator, Syneos HealthMichael McDonnell, MD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624946
- Sponsor's protocol ID
- ZK-001
- Status last verified
- Mar 2024
- First submitted
- 7 Aug 2018
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
White J, Tunga P, Anderson DM, Iledan K, Loreth T, Parrera GS, Astacio H, Drobic B, Richardson JS. Results of a Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Anti-Zika Virus Immunoglobulin. Am J Trop Med Hyg. 2021 Oct 4;105(6):1552-1562. doi: 10.4269/ajtmh.20-1578.
PubMed 34610572
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetic Evaluation of Zika Virus Immune Globulin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03624946
- Acronym / sponsor ID
- ZK-001
- Conditions
- Zika Virus Infection, Zika Virus Disease
- Keywords
- Zika virus, Human immune globulin, Hyperimmune, Polyclonal antibodies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers.
Detailed description
This study will be evaluating safety and pharmacokinetics (PK) of one dose level of ZIKV-IG (50 mL) in healthy adult volunteers. The study is a single-center, double-blind, randomized and placebo-controlled design. The primary objective is to assess safety of intravenously (IV) administered ZIKV-IG, while the secondary objective is to determine the PK profile of ZIKV-IG in healthy adult volunteers.
There will be a total of 30 subjects enrolled into the study; dosing of the first six subjects will be staggered over three separate days, wherein two subjects per day will be randomized 1:1 to either receive 50 mL of placebo IV or 50 mL of ZIKV-IG IV (the total amount of gamma immune globulin [IgG] protein from a single 50mL dose is 4.65g). After the first six subjects are dosed, the remaining 24 subjects will be randomized 2:1 to receive either ZIKV-IG or placebo. A safety monitoring committee will review safety data (collected up to 3 days post-dosing) of the first 12 dosed subjects prior to dosing of the remaining 18 subjects. Overall, there will be 19 subjects randomized to receive ZIKV-IG and 11 subjects randomized to receive placebo on Day 1. On Day 1 (post-dose at 1 hour, 3 hours, 8 hours) and Day 2, safety and PK assessments will be conducted while the subjects are in the Phase 1 clinic. After the discharge on Day 2, the subjects will come back to the clinic for safety and PK assessments on Days 3, 4, 6, 8, 10, 12, 15, 22, 29, 43, 57 and 85. Total study duration for each subject will be up to 4 months (from screening to Day 85).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zika Virus Immune Globulin (ZIKV-IG) | Experimental | Biological: Zika Virus Immune Globulin (ZIKV-IG)Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. |
| Placebo (Saline Solution) | Placebo comparator | Other: PlaceboSingle dose of 50 mL placebo will be administered intravenously over 33 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Informed consent voluntarily signed by subject.
- Age: 18-55 years of age.
- Blood type O+ or O-.
- Body mass index (BMI) of 18-30.
- For female subjects (with male partners) that are not surgically sterilized (e.g., did not undergo hysterectomy, bilateral oophorectomy or tubal ligation), use of an effective method of contraception throughout the trial including:
Key exclusion criteria (28 listed)
- Use of any investigational product within the past 30 days.
- Use of any investigational product during the study.
- Individuals with blood type A, B or AB.
- Recipient of any blood product within the past 12 months.
- Plasma donation within 7 days or significant blood loss or blood donation within 56 days of baseline.
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 |
|---|---|---|
| Zika Virus Immune Globulin (ZIKV-IG)Also: Anti-Zika Immune Globulin (Human), NP-024Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus. | Biological | Zika Virus Immune Globulin (ZIKV-IG) |
| PlaceboAlso: Saline solutionPlacebo is a normal saline solution (0.9% sodium chloride). | Other | Placebo (Saline Solution) |
Primary outcome
Number of Subjects With Adverse Events.
Time frame: Up to Day 85
Number of subjects with of adverse events by severity.
7 secondary outcomes
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Maximum Concentration (Cmax)
Time frame: 0-2 hours predose to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Time to Maximum Concentration (Tmax)
Time frame: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Up to Last Quantifiable Concentration (AUC0-t)
Time frame: 0-2 hours predose to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Extrapolated to Infinity (AUC0-inf)
Time frame: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Clearance (CL)
Time frame: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Half-Life (t1/2)
Time frame: 0-2 hours predose up to Day 85 postdose
Assessment of Zika Virus Immune Globulin (ZIKV-IG) Volume of Distribution (Vz)
Time frame: 0-2 hours predose up to Day 85 postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34610572White J, Tunga P, Anderson DM, Iledan K, Loreth T, Parrera GS, Astacio H, Drobic B, Richardson JS. Results of a Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Anti-Zika Virus Immunoglobulin. Am J Trop Med Hyg. 2021 Oct 4;105(6):1552-1562. doi: 10.4269/ajtmh.20-1578.
- 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.
Vadim Dreyzin, MD principal investigator
Syneos Health
Michael McDonnell, MD principal investigator
Syneos Health
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 Zika Virus Immune Globulin (ZIKV-IG) in people with Zika Virus Infection and Zika Virus Disease, run by Emergent BioSolutions at 1 site in Canada.
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 15 inclusion and 28 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 Mar 2024. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Adverse Events. (time frame: Up to Day 85). 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 NCT03624946, 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 Mar 2024.