A Phase 2/3 interventional study of Raxibacumab in Therapeutic Treatment of Inhalation Anthrax, sponsored by Human Genome Sciences Inc.. Completed. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-29.
Sponsored by Human Genome Sciences Inc. (part of GlaxoSmithKline) · Phase 2/3, Interventional, and Treatment
This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable female subjects) will receive a second dose of raxibacumab equal to that of the previous dose >= 4 months following the first dose. Subjects will remain in house from Day 0 until Day 1 and will be followed for 70 days after receiving the second dose of raxibacumab. Raxibacumab has been shown to provide improved survival in rabbit and monkey anthrax spore challenge studies. Preliminary data from our rabbit pivotal efficacy study showed significant survival benefit for raxibacumab over placebo. Exposure to anthrax and resulting clinical disease can occur more than once, especially in individuals who do not develop protective immunity. Hence, if clinically indicated for the treatment of anthrax, there may be a requirement for the repeat administration of raxibacumab. The rationale of the study is to evaluate the immunogenicity and safety of repeat administration of raxibacumab with a >= 4 month interval between dosing.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Human Genome Sciences Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.
First submitted after Human Genome Sciences Inc. became part of GlaxoSmithKline.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A maximum of 25 subjects (to include 3 evaluable female subjects) will receive a second dose of raxibacumab equal to that of the previous dose \>= 4 months following the first dose.
Biological: Raxibacumab
Raxibacumab will be supplied in 50 milliliter (mL) sterile, single-use vials containing 34.9 mL of liquid formulation per vial. Each vial contains 50 milligram (mg)/mL raxibacumab in 0.13 mg/mL citric acid, 2.8 mg/mL sodium citrate, 10 mg/mL sucrose, 18 mg/mL glycine, 0.2 mg/mL polysorbate 80, pH 6.5
Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response
Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With Hematological Toxicities of the Indicated Grade
Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities
The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With Liver Toxicities of the Indicated Grade
Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities
The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With Electrolyte Toxicities of the Indicated Grade
Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities
The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With Other Chemistry Toxicities of the Indicated Grade
Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities
The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With Urinalysis Toxicities of the Indicated Grade
Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities
Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 70
Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose
Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. Serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics
Time frame: From the date of the dose administration of study agent for this study (Day 0) until Day 56
Participants who had received raxibacumab \>= 4 months in another HGS study (study # HGS1021-C1064) prior to this study were eligible for enrollment in this study.
| Milestone | Raxibacumab |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.
| Participants | Raxibacumab |
|---|---|
| Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response | 0 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
| Participants | Raxibacumab |
|---|---|
| Any AE | 8 |
| Any SAE | 0 |
Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
| Participants | Raxibacumab |
|---|---|
| Leukocytosis, Grade 1 | 0 |
| Leukocytosis, Grade 2 | 0 |
| Leukocytosis, Grade 3 | 0 |
| Leukocytosis, Grade 4 | 0 |
| Leukopenia, Grade 1 | 5 |
| Leukopenia, Grade 2 | 0 |
| Leukopenia, Grade 3 | 0 |
| Leukopenia, Grade 4 | 0 |
| Lymphopenia, Grade 1 | 0 |
| Lymphopenia, Grade 2 | 1 |
| Lymphopenia, Grade 3 | 0 |
| Lymphopenia, Grade 4 | 0 |
| Neutropenia, Grade 1 | 2 |
| Neutropenia, Grade 2 | 0 |
| Neutropenia, Grade 3 | 0 |
| Neutropenia, Grade 4 | 0 |
| Hemoglobin, Grade 1 | 1 |
| Hemoglobin, Grade 2 | 0 |
| Hemoglobin, Grade 3 | 0 |
| Hemoglobin, Grade 4 | 0 |
| Platelet, Grade 1 | 0 |
| Platelet, Grade 2 | 0 |
| Platelet, Grade 3 | 0 |
| Platelet, Grade 4 | 0 |
| Prothrombin Time, Grade 1 | 0 |
| Prothrombin Time, Grade 2 | 0 |
| Prothrombin Time, Grade 3 | 0 |
| Prothrombin Time, Grade 4 | 1 |
| Partial Thromboplastin Time, Grade 1 | 0 |
| Partial Thromboplastin Time, Grade 2 | 1 |
| Partial Thromboplastin Time, Grade 3 | 0 |
| Partial Thromboplastin Time, Grade 4 | 0 |
The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
| Participants | Raxibacumab |
|---|---|
| Leukocytosis, any>=2-grade worsening | 0 |
| Leukopenia, any >=2-grade worsening | 0 |
| Lymphopenia, any>=2-grade worsening | 1 |
| Neutropenia, any >=2-grade worsening | 0 |
| Hemoglobin, any>=2-grade worsening | 0 |
| Platelet, any>=2-grade worsening | 0 |
| Prothrombin Time, any >=2-grade worsening | 1 |
| Partial Thromboplastin Time, any>=2grade worsening | 1 |
Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
| Participants | Raxibacumab |
|---|---|
| Aspartate amino transferase (AST), Grade 1 | 2 |
| AST, Grade 2 | 0 |
| AST, Grade 3 | 0 |
| AST, Grade 4 | 0 |
| Alanine amino transferase(ALT), Grade 1 | 1 |
| ALT, Grade 2 | 1 |
| ALT, Grade 3 | 0 |
| ALT, Grade 4 | 0 |
| Gamma-glutayl-transferase (GGT), Grade 1 | 0 |
| GGT, Grade 2 | 0 |
| GGT, Grade 3 | 0 |
| GGT, Grade 4 | 0 |
| Alkaline Phosphatase, Grade 1 | 0 |
| Alkaline Phosphatase, Grade 2 | 0 |
| Alkaline Phosphatase, Grade 3 | 0 |
| Alkaline Phosphatase, Grade 4 | 0 |
| Hyperbilirubinemia, Grade 1 | 0 |
| Hyperbilirubinemia, Grade 2 | 0 |
| Hyperbilirubinemia, Grade 3 | 0 |
| Hyperbilirubinemia, Grade 4 | 0 |
The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
| Participants | Raxibacumab |
|---|---|
| AST, any>=2-grade worsening | 0 |
| ALT, any>=2-grade worsening | 1 |
| GGT, any>=2-grade worsening | 0 |
| Alkaline phosphatase, any>=2-grade worsening | 0 |
| Hyperbilirubinemia, any>=2-grade worsening | 0 |
Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
| Participants | Raxibacumab |
|---|---|
| Hypernatremia, Grade 1 | 0 |
| Hypernatremia, Grade 2 | 0 |
| Hypernatremia, Grade 3 | 0 |
| Hypernatremia, Grade 4 | 0 |
| Hyponatremia, Grade 1 | 2 |
| Hyponatremia, Grade 2 | 0 |
| Hyponatremia, Grade 3 | 0 |
| Hyponatremia, Grade 4 | 0 |
| Hyperkalemia, Grade 1 | 1 |
| Hyperkalemia, Grade 2 | 0 |
| Hyperkalemia, Grade 3 | 0 |
| Hyperkalemia, Grade 4 | 0 |
| Hypokalemia, Grade 1 | 0 |
| Hypokalemia, Grade 2 | 0 |
| Hypokalemia, Grade 3 | 0 |
| Hypokalemia, Grade 4 | 0 |
| Hypomagnesemia, Grade 1 | 0 |
| Hypomagnesemia, Grade 2 | 0 |
| Hypomagnesemia, Grade 3 | 0 |
| Hypomagnesemia, Grade 4 | 0 |
| Hypercalcemia, Grade 1 | 0 |
| Hypercalcemia, Grade 2 | 0 |
| Hypercalcemia, Grade 3 | 0 |
| Hypercalcemia, Grade 4 | 0 |
| Hypocalcemia, Grade 1 | 0 |
| Hypocalcemia, Grade 2 | 0 |
| Hypocalcemia, Grade 3 | 0 |
| Hypocalcemia, Grade 4 | 0 |
| Hypophosphatemia, Grade 1 | 1 |
| Hypophosphatemia, Grade 2 | 0 |
| Hypophosphatemia, Grade 3 | 0 |
| Hypophosphatemia, Grade 4 | 0 |
The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
| Participants | Raxibacumab |
|---|---|
| Hypernatremia, any>=2-grade worsening | 0 |
| Hyponatremia, any>=2-grade worsening | 0 |
| Hyperkalemia, any>=2-grade worsening | 0 |
| Hypokalemia, any>=2-grade worsening | 0 |
| Hypomagnesemia, any>=2-grade worsening | 0 |
| Hypercalcemia, any>=2-grade worsening | 0 |
| Hypocalcemia, any>=2-grade worsening | 0 |
| Hypophosphatemia, any>=2-grade worsening | 0 |
Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
| Participants | Raxibacumab |
|---|---|
| Creatinine, Grade 1 | 0 |
| Creatinine, Grade 2 | 0 |
| Creatinine, Grade 3 | 0 |
| Creatinine, Grade 4 | 0 |
| Hypoalbuminemia, Grade 1 | 0 |
| Hypoalbuminemia, Grade 2 | 0 |
| Hypoalbuminemia, Grade 3 | 0 |
| Hypoalbuminemia, Grade 4 | 0 |
| Hyperuricemia, Grade 1 | 1 |
| Hyperuricemia, Grade 2 | 0 |
| Hyperuricemia, Grade 3 | 0 |
| Hyperuricemia, Grade 4 | 0 |
| Hyperglycemia, Grade 1 | 4 |
| Hyperglycemia, Grade 2 | 1 |
| Hyperglycemia, Grade 3 | 0 |
| Hyperglycemia, Grade 4 | 0 |
| Hypoglycemia, Grade 1 | 2 |
| Hypoglycemia, Grade 2 | 0 |
| Hypoglycemia, Grade 3 | 0 |
| Hypoglycemia, Grade 4 | 0 |
| Amylase, Grade 1 | 3 |
| Amylase, Grade 2 | 1 |
| Amylase, Grade 3 | 0 |
| Amylase, Grade 4 | 0 |
The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
| Participants | Raxibacumab |
|---|---|
| Creatinine, any>=2-grade worsening | 0 |
| Hypoalbuminemia, any>=2-grade worsening | 0 |
| Hyperuricemia, any>=2-grade worsening | 0 |
| Hyperglycemia, any>=2-grade worsening | 1 |
| Hypoglycemia, any>=2-grade worsening | 0 |
| Amylase, any>=2-grade worsening | 0 |
Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
| Participants | Raxibacumab |
|---|---|
| Number of Participants With Urinalysis Toxicities of the Indicated Grade | 0 |
Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (\< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
| Participants | Raxibacumab |
|---|---|
| Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities | 0 |
Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. Serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics
| Micrograms/milliliter (µg/mL) | Raxibacumab IV |
|---|---|
| Pre-dose | 1.358 ± 1.879 |
| 0.00347 hr | 979.078 ± 147.543 |
| 0.3333 hr | 865.874 ± 122.602 |
| Day 1 | 784.122 ± 118.680 |
| Day 3 | 580.068 ± 94.776 |
| Day 7 | 418.253 ± 62.350 |
| Day 14 | 300.589 ± 41.689 |
| Day 21 | 238.190 ± 39.515 |
| Day 28 | 208.646 ± 44.802 |
| Day 42 | 131.473 ± 44.308 |
| Day 56 | 96.932 ± 46.637 |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study agent (Day 0) until Day 70.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Raxibacumab | — | 0/20 (0%) | 8/20 (40%) |
| Event | Raxibacumab |
|---|---|
| HeadacheNervous system disorders | 3/20 |
| Upper respiratory tract infectionInfections and infestations | 1/20 |
| ContusionInjury, poisoning and procedural complications | 1/20 |
| PainGeneral disorders | 1/20 |
| Abdominal painGastrointestinal disorders | 1/20 |
| Joint stiffnessMusculoskeletal and connective tissue disorders | 1/20 |
| Dry skinSkin and subcutaneous tissue disorders | 1/20 |
| Age, Continuous(Years) | Raxibacumab |
|---|---|
| Mean | 40.6 ± 13.3 |
| Sex: Female, Male(Participants) | Raxibacumab |
|---|---|
| Female | 8 |
| Male | 12 |
| Race/Ethnicity, Customized(Participants) | Raxibacumab |
|---|---|
| White | 13 |
| Black or African American | 7 |
No study locations are listed for this record.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Studies of the drug tested here: Raxibacumab