A Phase 1 interventional study of VRC-EBOMAB092-00-AB (MAb114) in Healthy Adult Immune Responses to Vaccine, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-26.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
Background:
Ebola is a virus that has infected and killed people mostly in West Africa. There is no treatment or prevention for it, but several drugs are being studied. Researchers want to test the drug MAb114 in healthy people not exposed to Ebola to see whether it can be used for Ebola treatment in people who are infected in the future. This trial will not expose volunteers to the Ebola virus.
Objectives:
To see if MAb114 is safe and how a person's body responds to it.
Eligibility:
Healthy adults ages 18-60 who weigh 220.5 pounds or less
Design:
Participants will be screened under protocol NIH 11-I-0164 with:
Participants will have a first 8- to10-hour visit. They will get MAb114 by IV infusion. For this, a thin tube will be placed in an arm vein. They may get an IV line in their other arm to collect blood. Blood will be taken many times before and after the infusion. Participants may have a urine test.
Participants will get a thermometer to check their temperature for 3 days after they get MAb114. They will record their highest temperature and any symptoms.
Participants will have about 14 more study visits over 6 months. At each visit, they will have blood taken and be checked for any health changes. They will talk about how they are feeling and if they have taken any medications.
At the end of the 6 months, participants may be invited to take part in another study for follow-up sample collection.
VRC 608: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
Study Design: VRC 608 is the first-in-human Phase I study to examine safety, tolerability and pharmacokinetics of the monoclonal antibody (MAb), VRC-EBOMAB092-00-AB (MAb114). MAb114 will be administered as a single dose. The hypotheses are: 1) MAb114 administration to healthy adults will be safe by the intravenous (IV) route; and 2) MAb114 will be detectable in human sera with a definable half-life. The primary objectives are to evaluate the safety and tolerability of MAb114 in healthy adults. Secondary objectives will evaluate the pharmacokinetics of MAb114 and the potential to detect an anti-drug antibody response to MAb114.
Product Description: MAb114 is a human IgG1 MAb targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP). It was developed by the VRC/NIAID/NIH and manufactured at Cook Pharmica LLC d.b.a. Catalent Indiana, LLC (Bloomington, IN) under current Good Manufacturing Practice (cGMP) regulations. MAb114 is supplied as a lyophilized product in a glass vial at 400 mg per vial with target overfill to 425 mg per vial.
Subjects: Up to 30 healthy adults, 18-60 years of age.
Study Plan: This is an open-label, dose-escalation study of MAb114 administered by IV infusion at dosages of 5, 25 and 50 mg/kg (Groups 1-3). Enrollment will begin with the lowest dose group. Following the first product administration in each group, the study team will wait at least 3 days before administering MAb114 to a second subject within the same group. Dose-escalation evaluations will occur to ensure the safety data support proceeding to the higher doses. Solicited reactogenicity following product administration will be evaluated using a 3-day diary. Assessment of safety will include clinical observation and monitoring of serum hematological and chemical parameters at defined timepoints throughout the study.
Total* 18 subjects
Study Duration: Subjects will be followed for 24 weeks after the study product administration.
104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's enrollment of 19 is below the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A volunteer must meet all of the following criteria:
Have screening laboratory values within 84 days prior to enrollment that meet the following criteria:
Criteria applicable to women of :
EXCLUSION CRITERIA:
A volunteer will be excluded from study participation if one or more of the following conditions apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.
Biological: VRC-EBOMAB092-00-AB (MAb114)
Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.
Biological: VRC-EBOMAB092-00-AB (MAb114)
Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.
Biological: VRC-EBOMAB092-00-AB (MAb114)
VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).
Number of Subjects Experiencing Infusion Reaction During Product Administration
Possible infusion reaction symptoms: unusually tired/feeling unwell, muscles aches, headache, chills, rigors, nausea, fever, joint pain, urticaria/rash, and pruritus. Also information was collected if administration was slowed down or stopped for reactogenicity reasons.
Time frame: About 30 minutes of product administration
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Subjects recorded 3-day systemic reactogenicity symptoms in a diary after study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, fever and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects experiencing any systemic symptom as reported at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1.
Time frame: 3 days after product administration
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Local reactogenicity symptoms were assessed and recorded by clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that wasn't resolved within 7 days. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom as reported at the worst severity. Solicited reactogenicity was recorded without attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1.
Time frame: 7 days after product administration
Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events
Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 28 days after product administration. After the indicated time period through the last expected study visit at 24 weeks after product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity. The relationship between an AE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related - There is a reasonable possibility that the AE may be related to the study product and Not Related - There is not a reasonable possibility that the AE is related to the study product.
Time frame: Through 24 weeks after product administration
Number of Subjects Reporting Serious Adverse Events
Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after product administration. Grading done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1. The relationship between a SAE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related - There is a reasonable possibility that the SAE may be related to the study product and Not Related - There is not a reasonable possibility that the SAE is related to the study product.
Time frame: Through 24 weeks after product administration
Maximum Observed Serum Concentration (Cmax) of MAb114
Cmax is the peak serum concentration that MAb114 achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Time frame: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Time to Reach Maximum Observed Serum Concentration (Tmax) of MAb114
Tmax is the time it takes to reach Cmax of MAb114 after it has been administered; it is determined based on the summary PK curve for each study group.
Time frame: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Mean Serum Concentration of MAb114
The mean of individual subject MAb114 serum concentrations by administered dose group
Time frame: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Overall IV Half-life (T1/2) of MAb114
Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Time frame: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-56 days post-infusion
Area Under the Curve (AUC0-28D)
The AUC0-28D represents the total drug exposure in 28 days after MAb114 administration; it is determined based on the summary PK curve for each group.
Time frame: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Volume of Distribution (Vd) at Steady-state
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group.
Time frame: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
MAb114 Clearance Rate
Rate of MAb114 elimination divided by the plasma MAb114 concentration; determined based on the summary PK curve for each study group.
Time frame: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Number of Subjects Who Produced Anti-drug Antibodies to MAb114
Serum samples collected 28 days and 56 days after MAb114 administration
Time frame: Days 28 and 56 post-infusion
Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland
| Milestone | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV |
|---|---|---|---|
| Started | 3 | 5 | 11 |
| Received mab114 | 3 | 5 | 10 |
| Completed | 2 | 5 | 8 |
| Not completed | 1 | 0 | 3 |
| Withdrew: Enrolled, but product never administered | 0 | 0 | 1 |
| Withdrew: Moved from area | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 |
Possible infusion reaction symptoms: unusually tired/feeling unwell, muscles aches, headache, chills, rigors, nausea, fever, joint pain, urticaria/rash, and pruritus. Also information was collected if administration was slowed down or stopped for reactogenicity reasons.
| Participants | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=10) |
|---|---|---|---|
| Number who experienced infusion reaction | 0 | 0 | 0 |
| Number who completed infusion in about 30 min | 3 | 5 | 10 |
Subjects recorded 3-day systemic reactogenicity symptoms in a diary after study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, fever and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects experiencing any systemic symptom as reported at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1.
| Participants | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=10) | Overall (n=18) |
|---|---|---|---|---|
| Malaise — None | 3 | 4 | 8 | 15 |
| Malaise — Mild | 0 | 1 | 2 | 3 |
| Malaise — Moderate | 0 | 0 | 0 | 0 |
| Malaise — Severe | 0 | 0 | 0 | 0 |
| Myalgia — None | 3 | 4 | 9 | 16 |
| Myalgia — Mild | 0 | 1 | 1 | 2 |
| Myalgia — Moderate | 0 | 0 | 0 | 0 |
| Myalgia — Severe | 0 | 0 | 0 | 0 |
| Headache — None | 3 | 3 | 8 | 14 |
| Headache — Mild | 0 | 2 | 2 | 4 |
| Headache — Moderate | 0 | 0 | 0 | 0 |
| Headache — Severe | 0 | 0 | 0 | 0 |
| Chills — None | 3 | 4 | 9 | 16 |
| Chills — Mild | 0 | 1 | 1 | 2 |
| Chills — Moderate | 0 | 0 | 0 | 0 |
| Chills — Severe | 0 | 0 | 0 | 0 |
| Nausea — None | 3 | 4 | 9 | 16 |
| Nausea — Mild | 0 | 1 | 1 | 2 |
| Nausea — Moderate | 0 | 0 | 0 | 0 |
| Nausea — Severe | 0 | 0 | 0 | 0 |
| Fever — None | 3 | 5 | 10 | 18 |
| Fever — Mild | 0 | 0 | 0 | 0 |
| Fever — Moderate | 0 | 0 | 0 | 0 |
| Fever — Severe | 0 | 0 | 0 | 0 |
| Joint Pain — None | 3 | 4 | 9 | 16 |
| Joint Pain — Mild | 0 | 1 | 1 | 2 |
| Joint Pain — Moderate | 0 | 0 | 0 | 0 |
| Joint Pain — Severe | 0 | 0 | 0 | 0 |
| Any systemic symptom reported — None | 3 | 3 | 8 | 14 |
| Any systemic symptom reported — Mild | 0 | 2 | 2 | 4 |
| Any systemic symptom reported — Moderate | 0 | 0 | 0 | 0 |
| Any systemic symptom reported — Severe | 0 | 0 | 0 | 0 |
Local reactogenicity symptoms were assessed and recorded by clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that wasn't resolved within 7 days. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom as reported at the worst severity. Solicited reactogenicity was recorded without attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1.
| Participants | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=10) | Overall (n=18) |
|---|---|---|---|---|
| Pain/Tenderness — None | 3 | 5 | 10 | 18 |
| Pain/Tenderness — Mild | 0 | 0 | 0 | 0 |
| Pain/Tenderness — Moderate | 0 | 0 | 0 | 0 |
| Pain/Tenderness — Severe | 0 | 0 | 0 | 0 |
| Bruising — None | 3 | 5 | 10 | 18 |
| Bruising — Mild | 0 | 0 | 0 | 0 |
| Bruising — Moderate | 0 | 0 | 0 | 0 |
| Bruising — Severe | 0 | 0 | 0 | 0 |
| Swelling — None | 3 | 5 | 10 | 18 |
| Swelling — Mild | 0 | 0 | 0 | 0 |
| Swelling — Moderate | 0 | 0 | 0 | 0 |
| Swelling — Severe | 0 | 0 | 0 | 0 |
| Redness — None | 3 | 5 | 10 | 18 |
| Redness — Mild | 0 | 0 | 0 | 0 |
| Redness — Moderate | 0 | 0 | 0 | 0 |
| Redness — Severe | 0 | 0 | 0 | 0 |
| Pruritis — None | 3 | 5 | 10 | 18 |
| Pruritis — Mild | 0 | 0 | 0 | 0 |
| Pruritis — Moderate | 0 | 0 | 0 | 0 |
| Pruritis — Severe | 0 | 0 | 0 | 0 |
| Any Local Symptoms Reported — None | 3 | 5 | 10 | 18 |
| Any Local Symptoms Reported — Mild | 0 | 0 | 0 | 0 |
| Any Local Symptoms Reported — Moderate | 0 | 0 | 0 | 0 |
| Any Local Symptoms Reported — Severe | 0 | 0 | 0 | 0 |
Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 28 days after product administration. After the indicated time period through the last expected study visit at 24 weeks after product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity. The relationship between an AE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related - There is a reasonable possibility that the AE may be related to the study product and Not Related - There is not a reasonable possibility that the AE is related to the study product.
| Participants | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=10) | Overall (n=18) |
|---|---|---|---|---|
| Related to MAb114 Administration | 0 | 0 | 0 | 0 |
| Not Related to MAb114 Administration | 0 | 2 | 5 | 7 |
Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after product administration. Grading done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1. The relationship between a SAE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related - There is a reasonable possibility that the SAE may be related to the study product and Not Related - There is not a reasonable possibility that the SAE is related to the study product.
| Participants | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=10) | Overall (n=18) |
|---|---|---|---|---|
| Related to MAb114 Administration | 0 | 0 | 0 | 0 |
| Not Related to MAb114 Administration | 0 | 0 | 1 | 1 |
Cmax is the peak serum concentration that MAb114 achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
| µg/mL | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=5) |
|---|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of MAb114 | 198.45 ± 45.15 | 829.38 ± 237.40 | 1961.21 ± 339.83 |
Tmax is the time it takes to reach Cmax of MAb114 after it has been administered; it is determined based on the summary PK curve for each study group.
| hours | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=5) |
|---|---|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) of MAb114 | 3.21 ± 1.56 | 2.99 ± 2.16 | 2.75 ± 1.63 |
The mean of individual subject MAb114 serum concentrations by administered dose group
| µg/mL | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=5) |
|---|---|---|---|
| Concentration at Day 7 | 52.60 ± 22.19 | 373.12 ± 75.32 | 692.64 ± 201.63 |
| Concentration at Day 14 | 42.90 ± 5.53 | 272.91 ± 46.16 | 629.34 ± 118.19 |
| Concentration at Day 28 | 25.46 ± 5.96 | 180.19 ± 38.82 | 427.21 ± 88.43 |
| Average Concentration Days 0-28 | 52.87 ± 10.87 | 306.65 ± 32.14 | 663.87 ± 129.55 |
Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
| days | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=1) | Overall (n=9) |
|---|---|---|---|---|
| Overall IV Half-life (T1/2) of MAb114 | 20.1 ± 6.9 | 26.7 ± 3.8 | 23.6 | 24.2 ± 1.8 |
The AUC0-28D represents the total drug exposure in 28 days after MAb114 administration; it is determined based on the summary PK curve for each group.
| µg x day/mL | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=5) |
|---|---|---|---|
| Area Under the Curve (AUC0-28D) | 1480 ± 304 | 8586 ± 900 | 18588 ± 3627 |
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group.
| Liters | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=5) |
|---|---|---|---|
| Volume of Distribution (Vd) at Steady-state | 5.08 ± 0.88 | 3.93 ± 0.50 | 4.16 ± 0.74 |
Rate of MAb114 elimination divided by the plasma MAb114 concentration; determined based on the summary PK curve for each study group.
| mL/day | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=5) |
|---|---|---|---|
| MAb114 Clearance Rate | 199 ± 45 | 108 ± 21 | 115 ± 15 |
Serum samples collected 28 days and 56 days after MAb114 administration
| Participants | Group 1: 5 mg/kg IV (n=3) | Group 2: 25 mg/kg IV (n=5) | Group 3: 50 mg/kg IV (n=5) |
|---|---|---|---|
| Day 28: Subjects with Anti-drug antibodies | 0 | 0 | 0 |
| Day 56: Subjects with Anti-drug antibodies | 0 | 0 | 0 |
Collected over Solicited adverse events (AEs) included systemic AEs reported by subjects at the worst severity through 3 days post product administration; and local administration site AEs reported at the worst severity through 7 days post product administration. Unsolicited AEs were reported from the date of product administration through 28 days thereafter, and new chronic medical conditions and SAEs with onset any time following the date of product administration through 24 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: 5 mg/kg IV | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Group 2: 25 mg/kg IV | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Group 3: 50 mg/kg IV | 0/10 (0%) | 1/10 (10%) | 5/10 (50%) |
| Event | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV |
|---|---|---|---|
| SyncopeNervous system disorders | 0/3 | 0/5 | 1/10 |
| Event | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV |
|---|---|---|---|
| HeadacheNervous system disorders | 0/3 | 2/5 | 2/10 |
| Upper respiratory tract infectionInfections and infestations | 0/3 | 0/5 | 3/10 |
| HordeolumInfections and infestations | 0/3 | 1/5 | 0/10 |
| DyspepsiaGastrointestinal disorders | 0/3 | 1/5 | 0/10 |
| MalaiseGeneral disorders | 0/3 | 1/5 | 2/10 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/3 | 1/5 | 1/10 |
| ChillsGeneral disorders | 0/3 | 1/5 | 1/10 |
| NauseaGastrointestinal disorders | 0/3 | 1/5 | 1/10 |
| Joint PainMusculoskeletal and connective tissue disorders | 0/3 | 1/5 | 1/10 |
| Abdominal painGastrointestinal disorders | 0/3 | 0/5 | 1/10 |
All enrolled subjects
| Age, Continuous(years) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| Mean | 39.7 ± 7.4 | 36.4 ± 9.8 | 39.0 ± 13.9 | 38.4 ± 11.7 |
| Age, Customized(Participants) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| 21-30 years | 0 | 1 | 4 | 5 |
| 31-40 years | 2 | 2 | 2 | 6 |
| 41-50 years | 1 | 2 | 1 | 4 |
| 51-60 years | 0 | 0 | 4 | 4 |
| Sex: Female, Male(Participants) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| Female | 1 | 4 | 7 | 12 |
| Male | 2 | 1 | 4 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 2 |
| Not Hispanic or Latino | 3 | 4 | 10 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 |
| White | 2 | 5 | 7 | 14 |
| More than one race | 1 | 0 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| United States | 3 | 5 | 11 | 19 |
| Weight(kg) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| Mean | 88 ± 8.8 | 66.3 ± 12.6 | 73.5 ± 12.4 | 73.9 ± 13.4 |
| Education(Participants) | Group 1: 5 mg/kg IV | Group 2: 25 mg/kg IV | Group 3: 50 mg/kg IV | Total |
|---|---|---|---|---|
| College or University | 2 | 3 | 8 | 13 |
| Advanced Degree | 1 | 2 | 3 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Mar 2019, 10 months.
Of 16 phase 1 interventional studies under Hemorrhagic Fever, Ebola, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ansuvimab
National Institute of Allergy and Infectious Diseases (NIAID) →