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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 18-0016 | Other Identifier | DMID Protocol Number | |
| HHSN272201600028C | Other Identifier | NIAID Contract Number |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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AV-1 is a human monoclonal antibody (mAb) being investigated as a potential therapy for dengue, a mosquito-borne viral disease with extensive global public health impact. Globally, over 2 billion people are thought to be at risk of infection from the dengue virus and there are an estimated 390 million infections each year. Current treatment options for dengue are limited to supportive care, so a safe and effective treatment would provide substantial public health benefits. AV-1 has not previously been tested in humans. This study aims to determine the safety of AV-1 in healthy adult volunteers, when administered as a single IV infusion. The results of the study are based on the clinical study report and statistical analysis plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AV-1 30 mg | Experimental | Participants received a single intravenous (IV) infusion (infusion duration: 1 hour) of AV-1 30 mg on Day 1. |
|
| AV-1 90 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg on Day 1. |
|
| AV-1 250 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg on Day 1. |
|
| AV-1 500 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg on Day 1. |
|
| AV-1 1000 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg on Day 1. |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV-1 | Drug | Single dose, administered by IV infusion (volume: 250 mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Clinical laboratory abnormalities reported as TEAEs by the investigator. Clinical laboratory abnormalities were defined as any abnormal findings in analysis of hematology, serum chemistry, coagulation, and urine parameters. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. | Baseline up to Day 120 (± 5 days) |
| Number of Participants With Physical Examination Abnormalities Reported as TEAEs | A full physical examination included examination of skin; head, ears, eyes, nose, throat (HEENT); neck; thyroid; lungs; heart; cardiovascular; abdomen; lymph nodes; and musculoskeletal system/extremities. Focused examination included lungs, cardiovascular, abdomen, and skin. Investigator could perform targeted, symptom-directed physical examination. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. | Baseline up to Day 120 (± 5 days) |
| Number of Participants With Vital Sign Abnormalities Reported as TEAEs | Vital sign measurements included systolic and diastolic blood pressure, oral body temperature, heart rate, and respiratory rate. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. | Baseline up to Day 120 (± 5 days) |
| Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities Reported as TEAEs | Number of participants with abnormal 12-lead ECG reported as a TEAE of electrocardiogram QT prolonged by the investigator. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-infinity) of AV-1 | AUC0-infinity was calculated as: AUC from time 0 to the last quantifiable concentration (AUC0-tlast) + (last observed serum drug concentration [Ct] / Apparent terminal elimination rate constant [λz]). | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
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Inclusion Criteria:
Subject must be in good health at Screening (reaffirmed at Check-in):
Women who are not pregnant and/or not lactating.
Female subjects, including postmenopausal women and surgically sterile women, must have a negative serum pregnancy test at Screening, Check-in and on admission to the study facility.
Female subjects must fulfill one of the following criteria:
Male subjects who are biologically capable of fathering children must agree and commit to using an adequate form of double-barrier contraception, and refrain from sperm donation from Check-in until the final follow-up visit on Day 120 (± 5 days). A male subject is considered capable of fathering children even if his sexual partner is sterile or using contraceptives.
Body Mass Index between 18.5 and 29.9 kg/m^2 inclusive.
Must not have traveled outside the USA within 60 days prior to Check-in, and agree not to travel outside the USA through the final follow-up visit on Day 120 (± 5 days).
Must agree to abide by study restrictions and be willing to sign an informed consent form (ICF).
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Wood-Horrall, MD | PPD Development, LP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Austin Clinic, 7551 Metro Center Drive, Suite 200 | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42253092 | Derived | Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21. |
| Label | URL |
|---|---|
| FDA Medical Product Safety Information | View source |
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On the first day of dosing in all cohorts, the first group in each cohort comprised 2 sentinel participants: 1 was randomly assigned to receive AV-1 and the other was randomly assigned to receive placebo. After the Investigator reviewed the safety data from the 72-hour post-dose period for the sentinel participants, the remainder of the cohort (5 participants randomly assigned to AV-1; 1 participant randomly assigned to placebo) were dosed at least 72 hours after the sentinel participants.
This was a single-center study conducted in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | AV-1 30 mg | Participants received a single intravenous (IV) infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1. |
| FG001 | AV-1 90 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1. |
| FG002 | AV-1 250 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1. |
| FG003 | AV-1 500 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1. |
| FG004 | AV-1 1000 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1. |
| FG005 | Placebo | Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety population included all participants who received any amount of the investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | AV-1 30 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1. |
| BG001 | AV-1 90 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Clinical laboratory abnormalities reported as TEAEs by the investigator. Clinical laboratory abnormalities were defined as any abnormal findings in analysis of hematology, serum chemistry, coagulation, and urine parameters. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. | The Safety population included all participants who received any amount of the investigational product. | Posted | Count of Participants | Participants | No | Baseline up to Day 120 (± 5 days) |
|
Baseline up to Day 120 (± 5 days)
The Safety population included all participants who received any amount of the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AV-1 30 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 30 mg (volume: 250 mL) on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Urban Ramstedt | AbViro LLC | 617-818-8112 | urban.ramstedt@abviro.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2021 | Sep 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2021 | Sep 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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Participants received a single IV infusion (infusion duration: 1 hour) of placebo matched to AV-1 on Day 1.
|
| Placebo | Drug | 0.9% sterile saline. Administered by IV infusion (volume: 250 mL) |
|
| Baseline up to Day 120 (± 5 days) |
| Number of Participants With TEAEs | An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. | Baseline up to Day 120 (± 5 days) |
| Number of Participants With Serious Adverse Events (SAEs) | An AE or suspected adverse reaction was considered an SAE if, in the view of either the Investigator or Sponsor, it resulted in any of the following outcome:
Important medical events that did not result in death, was life-threatening, or required hospitalizations could have been considered serious when, based upon appropriate medical judgment, they jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed in this definition. | Baseline up to Day 120 (± 5 days) |
| Number of Participants by Severity of AEs | AEs were assessed by the Investigator as Mild (Grade 1), Moderate (Grade 2), or Severe (Grade 3). Mild (Grade 1): Events that were transient and required only minimal or no treatment or therapeutic intervention and did not interfere with the participants usual activities of daily living. Moderate (Grade 2): Events that were alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the participant. Severe (Grade 3): Events interrupted usual activities of daily living, or significantly affected clinical status, or required intensive therapeutic intervention. Severe events were usually incapacitating. | Baseline up to Day 120 (± 5 days) |
| AUC From Time 0 to 48 Hours Postdose (AUC0-48) of AV-1 | AUC0-48 was calculated using the linear trapezoidal rule method. | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion |
| AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) | AUC0-tlast was calculated using the linear trapezoidal method. | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
| Maximum Observed Serum Concentration (Cmax) of AV-1 | Cmax is defined as maximum observed serum drug concentration. | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
| Time to Reach Cmax (Tmax) of AV-1 | Tmax is defined as Time to reach maximum serum concentration following drug administration. | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
| Apparent Terminal Half-life (t1/2) of AV-1 | t1/2 is defined as terminal half-life, calculated as: ln(2)/ λz, where λz is apparent terminal elimination rate constant. | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
| Total Serum Clearance (CL) of AV-1 | Total serum clearance was calculated as dose divided by AUC0-infinity. | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
| Volume of Distribution During the Terminal Phase (Vz) of AV-1 | Volume of distribution during the terminal phase was calculated as dose divided by (AUC0-infinity*λz). | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
| Number of Participants With Detectable Anti-AV-1 Antibody | Serum samples for measurement of anti-AV-1 antibody levels were analyzed by a validated electrochemiluminescence enzyme-linked immunosorbent assay method used for detection and confirmation of pre-existing and treatment-emergent anti-AV-1 antibodies in serum samples based on the MesoScale Discovery platform that utilized labeled AV-1 for detection of anti-AV-1 antibodies and treatment-emergent antibodies. Number of participants with detectable anti-AV-1 antibody | Baseline, Days 29 (±2), 85 (±5), and 120 (±5) |
| FDA Recalls, Market Withdrawals, and Safety Alerts | View source |
| Participant non-compliance |
|
| Positive urine drug screen |
|
| BG002 | AV-1 250 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1. |
| BG003 | AV-1 500 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1. |
| BG004 | AV-1 1000 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1. |
| BG005 | Placebo | Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| OG001 | AV-1 90 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1. |
| OG002 | AV-1 250 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1. |
| OG003 | AV-1 500 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1. |
| OG004 | AV-1 1000 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1. |
| OG005 | Placebo | Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1. |
|
|
| Primary | Number of Participants With Physical Examination Abnormalities Reported as TEAEs | A full physical examination included examination of skin; head, ears, eyes, nose, throat (HEENT); neck; thyroid; lungs; heart; cardiovascular; abdomen; lymph nodes; and musculoskeletal system/extremities. Focused examination included lungs, cardiovascular, abdomen, and skin. Investigator could perform targeted, symptom-directed physical examination. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. | Participants in the Safety Population were evaluated. | Posted | Count of Participants | Participants | No | Baseline up to Day 120 (± 5 days) |
|
|
|
| Primary | Number of Participants With Vital Sign Abnormalities Reported as TEAEs | Vital sign measurements included systolic and diastolic blood pressure, oral body temperature, heart rate, and respiratory rate. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. | Participants in the Safety Population were analyzed. | Posted | Count of Participants | Participants | No | Baseline up to Day 120 (± 5 days) |
|
|
|
| Primary | Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities Reported as TEAEs | Number of participants with abnormal 12-lead ECG reported as a TEAE of electrocardiogram QT prolonged by the investigator. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related. | Participants in the Safety Population were analyzed. | Posted | Count of Participants | Participants | No | Baseline up to Day 120 (± 5 days) |
|
|
|
| Primary | Number of Participants With TEAEs | An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. | Participants in the Safety Population were evaluated. | Posted | Count of Participants | Participants | No | Baseline up to Day 120 (± 5 days) |
|
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | An AE or suspected adverse reaction was considered an SAE if, in the view of either the Investigator or Sponsor, it resulted in any of the following outcome:
Important medical events that did not result in death, was life-threatening, or required hospitalizations could have been considered serious when, based upon appropriate medical judgment, they jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed in this definition. | Participants in the Safety Population were analyzed. | Posted | Count of Participants | Participants | No | Baseline up to Day 120 (± 5 days) |
|
|
|
| Primary | Number of Participants by Severity of AEs | AEs were assessed by the Investigator as Mild (Grade 1), Moderate (Grade 2), or Severe (Grade 3). Mild (Grade 1): Events that were transient and required only minimal or no treatment or therapeutic intervention and did not interfere with the participants usual activities of daily living. Moderate (Grade 2): Events that were alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the participant. Severe (Grade 3): Events interrupted usual activities of daily living, or significantly affected clinical status, or required intensive therapeutic intervention. Severe events were usually incapacitating. | Participants in the Safety Population who experienced any AE were analyzed. | Posted | Count of Participants | Participants | No | Baseline up to Day 120 (± 5 days) |
|
|
|
| Secondary | Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-infinity) of AV-1 | AUC0-infinity was calculated as: AUC from time 0 to the last quantifiable concentration (AUC0-tlast) + (last observed serum drug concentration [Ct] / Apparent terminal elimination rate constant [λz]). | The pharmacokinetic (PK) population included participants who received the full dose of AV-1 and had at minimum all samples from predose through 1.5 hours from the start of infusion and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*hour/mL | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
|
|
|
| Secondary | AUC From Time 0 to 48 Hours Postdose (AUC0-48) of AV-1 | AUC0-48 was calculated using the linear trapezoidal rule method. | Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*hour/mL | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion |
|
|
|
| Secondary | AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) | AUC0-tlast was calculated using the linear trapezoidal method. | Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*hour/mL | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of AV-1 | Cmax is defined as maximum observed serum drug concentration. | Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
|
|
|
| Secondary | Time to Reach Cmax (Tmax) of AV-1 | Tmax is defined as Time to reach maximum serum concentration following drug administration. | Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Median | Full Range | hours | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
|
|
|
| Secondary | Apparent Terminal Half-life (t1/2) of AV-1 | t1/2 is defined as terminal half-life, calculated as: ln(2)/ λz, where λz is apparent terminal elimination rate constant. | Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
|
|
|
| Secondary | Total Serum Clearance (CL) of AV-1 | Total serum clearance was calculated as dose divided by AUC0-infinity. | Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
|
|
|
| Secondary | Volume of Distribution During the Terminal Phase (Vz) of AV-1 | Volume of distribution during the terminal phase was calculated as dose divided by (AUC0-infinity*λz). | Participants in the PK Population who have were analyzed. As placebo group did not receive AV-1, PK analysis for placebo group is not applicable. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Predose (within 15 minutes); at 0.5, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours after the start of infusion; Days 5, 8, 15, 22, 29, 43, 57, 85, and 120 |
|
|
|
| Secondary | Number of Participants With Detectable Anti-AV-1 Antibody | Serum samples for measurement of anti-AV-1 antibody levels were analyzed by a validated electrochemiluminescence enzyme-linked immunosorbent assay method used for detection and confirmation of pre-existing and treatment-emergent anti-AV-1 antibodies in serum samples based on the MesoScale Discovery platform that utilized labeled AV-1 for detection of anti-AV-1 antibodies and treatment-emergent antibodies. Number of participants with detectable anti-AV-1 antibody | Participants in the Safety Population were analyzed. | Posted | Count of Participants | Participants | No | Baseline, Days 29 (±2), 85 (±5), and 120 (±5) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | AV-1 90 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg (volume: 250 mL) on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | AV-1 250 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg (volume: 250 mL) on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | AV-1 500 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg (volume: 250 mL) on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | AV-1 1000 mg | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg (volume: 250 mL) on Day 1. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG005 | Placebo | Participants received a single IV infusion (infusion duration: 1 hour) of placebo (volume: 250 mL) on Day 1. | 0 | 11 | 0 | 11 | 3 | 11 |
| Feeling hot | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Infusion site discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| Cardiovascular |
|
| Musculoskeletal system/extremities |
|
| Heart |
|
| HEENT |
|
| Lungs |
|
| Lymph nodes |
|
| Neck |
|
| Skin (dermatitis contact) |
|
| Thyroid |
|
| Moderate |
|
| Severe |
|
| Day 29 (±2) |
|
| Day 85 (±5) |
|
| Day 120 (±5) |
|