HealthyPhase 1NCT02389192
Safety and Pharmacokinetics of a Single ZMappTM Administration in Healthy Adult Volunteers
A Phase 1 study testing ZMAPP in people with Healthy, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
Background: Ebola is a virus that can spread quickly and causes serious disease. It is currently causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a new drug made of natural infection-fighting substances. Researchers want to see if it can treat Ebola. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ZMAPP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2015to 27 Dec 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthy volunteers 18 to 50 years of age, inclusive.
- Able to understand and provide written informed consent.
- Body mass index 18 kg/m2 to 29 kg/m2, inclusive, at time of screening.
- Female subjects must be of non-childbearing potential (e.g., be confirmed postmenopausal or have undergone surgical sterilization) or must, in conjunction with their sexual partner(s), use a highly effective contraceptive (namely, a long-acting reversible method (IUD, injectable, or implant), or a combination of oral contraception in conjunction with a male condom) during the screening period and for at least 30 days after the infusion of study medication.
- Male subjects must either be sterile or agree to use, for the entire duration of the study, a male condom; the female sexual partner must also use a medically acceptable form of birth control (e.g., oral contraceptives), or a highly effective contraceptive (as described in #4 above).
- Male subjects must agree to not donate sperm for at least 30 days after the infusion of study medication.
Who cannot join
- Pregnancy or breastfeeding.
- A positive urine or blood screen for drugs of abuse at time of screening.
- Prior use of any medical intervention involving antibody products.
- Active substance abuse or any medical or psychiatric condition that, in the opinion of the principal investigator, could jeopardize the subject's safety or the subject's ability to comply with the protocol requirements.
- Any chronic medical problem that requires daily medications (except Tylenol, oral contraceptives, vitamins, eye drops, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase 1 drug.
- Allergy or intolerance of antihistamines, acetominophen, or catabolic steroids.
Show all 18Show fewer
- Active participation in any interventional clinical trial within 6 months prior to the dosing on Day 0 (i.e., received any other investigational drug).
- Prolonged QTcF interval > 440 ms for males or > 460 ms for females.
- Other clinically significant ECG abnormality, as determined by the principal investigator.
- Any clinically significant abnormal hematology, chemistry, coagulation, or urinalysis value, as determined by the principal investigator.
- Glomerular filtration rate (GFR) of < 80 mL/min, based on the Modification of Diet in Renal Disease equation.
- Urine-albumin-to-creatinine ratio (UACR) > 30 mg/g.
- Positive serology for Hepatitis B surface antigen
- Positive serology for Anti Hepatitis C Antibody
- Positive ELISA for HIV
- Known or suspected exposure to Ebola virus.
- Received investigational vaccine for prevention of EVD.
- Received investigational treatment for EVD.
About this study
Official title: A Phase 1a Open-Label Study to Assess the Safety and Pharmacokinetics of a Single ZMappTM Administration in Healthy Adult Volunteers
Background:
- Ebola is a virus that can spread quickly and causes serious disease. It is currently causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a new drug made of natural infection-fighting substances. Researchers want to see if it can treat Ebola.
Read more
Objective:
- To assess the safety of ZMappTM and how the body processes it. To measure the immune system response to ZMappTM.
Eligibility:
- Healthy people 18 50 years old.
Design:
- Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have an electrocardiogram (ECG) to measure heart electrical activity. Small pads will be stuck to the arms, legs, and chest.
- Participants will be admitted to the hospital. They will have a physical exam, medication review, and blood samples.
- Two intravenous (IV) lines will be placed into separate arm veins. A needle will be used to guide plastic tubing into the veins. One will be used to take blood samples. The other will be used to give the study drug.
- Participants will be given drugs to help prevent side effects.
- Participants will be given the study drug by IV over 10 12 hours. Participants will be monitored closely and vital signs taken frequently. They may have another ECG.
- Blood samples will be taken before, during, and after the infusion.
- Participants will stay in the hospital 1 or 2 nights after receiving the drug.
- Participants will have several study visits over 90 days after getting the study drug. They will be asked about side effects. They may have a physical exam, and blood may be drawn.
Read the detailed description
Ebola virus (EBOV) is associated with high morbidity and mortality rates in patients presenting clinical illness. Currently, no agent is approved in the U.S. or elsewhere for the therapeutic treatment of EBOV. The current standard of care for EBOV infection is limited to supportive treatment.
ZMapp TM, a combination of three chimeric human/murine monoclonal antibodies against the EBOV surface glycoprotein found on virions and infected cells, is being developed as a treatment for Ebola virus disease. This is a Phase 1a, open-label study to assess the safety and pharmacokinetics of a single intravenous administration of ZMapp tm in healthy adult volunteers. Three subjects will receive a single intravenous dose of 50mg/kg infusion and be evaluated on study Days 0, 1, 2, 7, 14, 21, 28, 60, and 90. Samples will be collected for pharmacokinetic and immunogenicity assessments at baseline, during, and following infusion. Subjects will be monitored and assessed for safety and the incidence of adverse events over the course of the study.
- Conditions
- Healthy
- Being tested
- ZMAPP
- Keywords
- Ebola, Mono-clonal Antibody
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZMAPPDrug
ZMappTM, a combination of three mouse/human chimeric monoclonal antibodies (mAbs; c4G6, c2G4, and c13C6-FR1) directed against Ebola virus glycoprotein epitopes
| Study group | Role | What they receive |
|---|---|---|
| OPEN | Experimental | healthy volunteers between the ages of 18-50 to receive a one-time infusion of Zmapp at a dose of 50mg/kg. Receives: Drug: ZMAPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of a single IV infusion of 50 mg/kg of ZMappTM
Measured: at 8 time points through 90 days following infusion
To determine serum pharmacokinetics following an intravenous (IV) infusion of 50 mg/kg of ZMappTM
Measured: at 8 time points through 90 days following infusion
Secondary outcomes (1)
To assess the development of anti-drug antibodies (ADAs) elicited following a single IV infusion of 50 mg/kg of ZMappTM
Measured: at 8 time points through 90 days following infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start11 Mar 2015
- Primary completion27 Dec 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard T Davey, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389192
- Sponsor's protocol ID
- 150094
- Other IDs
- 15-I-0094
- Status last verified
- 27 Dec 2017
- First submitted
- 11 Mar 2015
- Last updated
- 16 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a Open-Label Study to Assess the Safety and Pharmacokinetics of a Single ZMappTM Administration in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02389192
- Acronym / sponsor ID
- 150094
- Conditions
- Healthy
- Keywords
- Ebola, Mono-clonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 11 Mar 2015
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
Background:
- Ebola is a virus that can spread quickly and causes serious disease. It is currently causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a new drug made of natural infection-fighting substances. Researchers want to see if it can treat Ebola.
Objective:
- To assess the safety of ZMappTM and how the body processes it. To measure the immune system response to ZMappTM.
Eligibility:
- Healthy people 18 50 years old.
Design:
- Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have an electrocardiogram (ECG) to measure heart electrical activity. Small pads will be stuck to the arms, legs, and chest.
- Participants will be admitted to the hospital. They will have a physical exam, medication review, and blood samples.
- Two intravenous (IV) lines will be placed into separate arm veins. A needle will be used to guide plastic tubing into the veins. One will be used to take blood samples. The other will be used to give the study drug.
- Participants will be given drugs to help prevent side effects.
- Participants will be given the study drug by IV over 10 12 hours. Participants will be monitored closely and vital signs taken frequently. They may have another ECG.
- Blood samples will be taken before, during, and after the infusion.
- Participants will stay in the hospital 1 or 2 nights after receiving the drug.
- Participants will have several study visits over 90 days after getting the study drug. They will be asked about side effects. They may have a physical exam, and blood may be drawn.
Detailed description
Ebola virus (EBOV) is associated with high morbidity and mortality rates in patients presenting clinical illness. Currently, no agent is approved in the U.S. or elsewhere for the therapeutic treatment of EBOV. The current standard of care for EBOV infection is limited to supportive treatment.
ZMapp TM, a combination of three chimeric human/murine monoclonal antibodies against the EBOV surface glycoprotein found on virions and infected cells, is being developed as a treatment for Ebola virus disease. This is a Phase 1a, open-label study to assess the safety and pharmacokinetics of a single intravenous administration of ZMapp tm in healthy adult volunteers. Three subjects will receive a single intravenous dose of 50mg/kg infusion and be evaluated on study Days 0, 1, 2, 7, 14, 21, 28, 60, and 90. Samples will be collected for pharmacokinetic and immunogenicity assessments at baseline, during, and following infusion. Subjects will be monitored and assessed for safety and the incidence of adverse events over the course of the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPEN | Experimental | Drug: ZMAPPhealthy volunteers between the ages of 18-50 to receive a one-time infusion of Zmapp at a dose of 50mg/kg. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (18 listed)
- Pregnancy or breastfeeding.
- A positive urine or blood screen for drugs of abuse at time of screening.
- Prior use of any medical intervention involving antibody products.
- Active substance abuse or any medical or psychiatric condition that, in the opinion of the principal investigator, could jeopardize the subject's safety or the subject's ability to comply with the protocol requirements.
- Any chronic medical problem that requires daily medications (except Tylenol, oral contraceptives, vitamins, eye drops, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase 1 drug.
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 |
|---|---|---|
| ZMAPPZMappTM, a combination of three mouse/human chimeric monoclonal antibodies (mAbs; c4G6, c2G4, and c13C6-FR1) directed against Ebola virus glycoprotein epitopes | Drug | OPEN |
Primary outcome
To evaluate the safety of a single IV infusion of 50 mg/kg of ZMappTM
Time frame: at 8 time points through 90 days following infusion
To determine serum pharmacokinetics following an intravenous (IV) infusion of 50 mg/kg of ZMappTM
Time frame: at 8 time points through 90 days following infusion
1 secondary outcome
To assess the development of anti-drug antibodies (ADAs) elicited following a single IV infusion of 50 mg/kg of ZMappTM
Time frame: at 8 time points through 90 days following infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Richard T Davey, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZMAPP in people with Healthy, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 6 inclusion and 18 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: withdrawn, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the safety of a single IV infusion of 50 mg/kg of ZMappTM (time frame: at 8 time points through 90 days following infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2019.