Healthy VolunteersPhase 1NCT04273217
A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers
A Phase 1 study testing AV-1 in people with Healthy Volunteers, run by AbViro LLC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AV-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 8 Jul 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be in good health at Screening (reaffirmed at Check-in):
- Good health is defined by the absence of a medical condition described in the exclusion criteria of the study protocol, and based on screening medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG).
- If the subject has another current, ongoing chronic medical condition, the condition cannot: (i) Be first diagnosed within 3 months of enrollment; or (ii) Be a pre-existing medical condition that is not exclusionary but has worsened in terms of clinical outcome within 3 months of enrollment; or (iii) Involve the need for medication that may pose a risk to the subject's safety or impede assessment of adverse events (AEs) or anti-AV-1 antibody response if they participate in the study.
- 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:
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- Postmenopausal women must have had ≥ 12 months of spontaneous amenorrhea with follicle-stimulating hormone concentration consistently ≥40 mIU/mL and must have a negative pregnancy test result at Screening and Check-in.
- Surgically sterile women - those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation, must provide documentation of the procedure and must have a negative pregnancy test at Screening and Check-in.
- Must be willing to not engage in sexual intercourse from Check-in until the final follow-up visit on Day 120 (± 5 days).
- Must be willing to use an acceptable method of birth control until the final follow-up visit on Day 120 (± 5 days) as defined by the protocol and Investigator.
- 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).
Who cannot join
- Any significant medical condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participating for that subject, based on the Investigator's Brochure and the safety profile of AV-1.
- Subject has one or more symptoms of a urinary tract infection (e.g. dysuria, frequent, urgency, or suprapubic pain) at Screening or Check-in.
- Has certain abnormal12-lead ECG (electrocardiogram) results according to the protocol, as assessed by the Investigator.
- Has abnormal laboratory values for certain hematology, serum chemistry, coagulation, or urinalysis tests according to the protocol, as assessed by the Investigator.
- Is positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody types 1 and 2 within 35 days of enrollment.
- Has any psychiatric condition or history of psychiatric condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject.
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- Is unwilling to abstain from alcohol, caffeine-, or other xanthine-containing foods or beverages, tobacco or nicotine-containing products, and all bergamottin-containing fruits and fruit juices (e.g. Seville oranges, grapefruit/grapefruit juice, pomelos, pomegranate/pomegranate juice, cranberries/cranberry juice) 72 hours prior to Check-in, through discharge on Day 5 of the study.
- Is unwilling to abstain from strenuous exercise 7 days before Check-in through Day 15 of the study.
- Has a history of alcoholism or drug/chemical abuse within 6 months prior to Check-in.
- Has excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to approximately 1/2 pint [200 mL] beer, 1 small glass [100 mL] wine, or 1 measure [25 mL] spirits).
- Has a positive urine drug screen at Screening or Check-in.
- Has a positive cotinine urine test at Check-in.
- Has any confirmed or suspected immunosuppressive or immunodeficient condition, including but not limited to human immunodeficiency virus infection, or use of anti-cancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to Screening.
- Provides verbal history of vaccination with a licensed or investigational flavivirus vaccine for any of the following diseases: Zika virus, dengue virus (DENV), yellow fever virus, Japanese encephalitis virus, West Nile virus, St. Louis encephalitis virus, or tick-borne encephalitis virus; or reportedly diagnosed with a flavivirus infection or disease.
- Plans to receive a licensed flavivirus vaccine or participate in flavivirus vaccine trial during the study.
- Is positive for DENV or West Nile virus by immunoglobulin M, or immunoglobulin G, or Zika by immunoglobulin M serology testing within 35 days of enrollment.
- Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- Has had major surgery within 3 months prior to Screening or plans to have major surgery during the study through the final follow-up on Day 120 (± 5 days).
- Has been treated for a medical condition with a licensed monoclonal or polyclonal antibody in the past; or dosed in a clinical study involving administration of an investigational monoclonal or polyclonal antibody in the 18 months prior to study drug administration on Day 1.
- Has received an investigational drug within 28 days of study drug administration on Day 1.
- Has used any prohibited medication within 30 days prior to Check-in, or plans to use prohibited medication during the study. Prohibited medications include: Immunosuppressive drugs, immune modulators (except acetaminophen), oral corticosteroids, inhaled or intranasal steroids (<800 µg/day beclomethasone is acceptable), and anti-neoplastic agents. Topical steroids are acceptable.
- Has received or plans to receive any live vaccination, experimental or otherwise, within 28 days prior to or after Day 1 of the study; and receipt or planned receipt of an inactivated vaccination (or any COVID-19 vaccine), experimental or otherwise, within 14 days prior to or after Day 1 of the study.
- Has received blood products within 60 days prior to Check-in.
- Has donated or lost more than 450 mL of blood or plasma within 56 days of study drug infusion on Day 1. The subject must also agree to refrain from donating blood or plasma during the study.
- Has poor peripheral venous access.
- Previously completed or withdrawn from this study.
- Is a current clinical site staff paid entirely or partially by the contractor for this trial, or staff who are supervised by the Investigator or subinvestigators.
- In the opinion of the Investigator (or designee), the subject is not suitable for entry into the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Austin Clinic, 7551 Metro Center Drive, Suite 200
Austin, Texas, 78744
About this study
Official title: A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Determine the Safety and Pharmacokinetics of AV-1 in Healthy Male and Female Adult Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- AV-1, Placebo
- Keywords
- Healthy volunteers, Monoclonal antibody, AV-1, Safety, Dengue
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-1Drug
Single dose, administered by IV infusion (volume: 250 mL)
PlaceboDrug
0.9% sterile saline. Administered by IV infusion (volume: 250 mL)
| Study group | Role | What they receive |
|---|---|---|
| AV-1 30 mg | Experimental | Participants received a single intravenous (IV) infusion (infusion duration: 1 hour) of AV-1 30 mg on Day 1. Receives: Drug: AV-1 |
| AV-1 90 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg on Day 1. Receives: Drug: AV-1 |
| AV-1 250 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg on Day 1. Receives: Drug: AV-1 |
| AV-1 500 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg on Day 1. Receives: Drug: AV-1 |
| AV-1 1000 mg | Experimental | Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg on Day 1. Receives: Drug: AV-1 |
| Placebo | Placebo comparator | Participants received a single IV infusion (infusion duration: 1 hour) of placebo matched to AV-1 on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Death
- A life-threatening AE
- Inpatient hospitalization or prolongation of existing hospitalization
- a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
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.
Measured: 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.
Measured: Baseline up to Day 120 (± 5 days)
Secondary outcomes (9)
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]).
Measured: 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
AUC From Time 0 to 48 Hours Postdose (AUC0-48) of AV-1
AUC0-48 was calculated using the linear trapezoidal rule method.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Baseline, Days 29 (±2), 85 (±5), and 120 (±5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start4 Feb 2020
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbViro LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Wood-Horrall, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273217
- Sponsor's protocol ID
- AV1-PPD-0005
- Other IDs
- DMID 18-0016, HHSN272201600028C
- Status last verified
- Oct 2022
- First submitted
- 14 Feb 2020
- Last updated
- 31 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42253092
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Determine the Safety and Pharmacokinetics of AV-1 in Healthy Male and Female Adult Subjects
- ClinicalTrials.gov ID
- NCT04273217
- Acronym / sponsor ID
- AV1-PPD-0005
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Monoclonal antibody, AV-1, Safety, Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AbViro LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 31 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AV-1 30 mg | Experimental | Drug: AV-1Participants received a single intravenous (IV) infusion (infusion duration: 1 hour) of AV-1 30 mg on Day 1. |
| AV-1 90 mg | Experimental | Drug: AV-1Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 90 mg on Day 1. |
| AV-1 250 mg | Experimental | Drug: AV-1Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 250 mg on Day 1. |
| AV-1 500 mg | Experimental | Drug: AV-1Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 500 mg on Day 1. |
| AV-1 1000 mg | Experimental | Drug: AV-1Participants received a single IV infusion (infusion duration: 1 hour) of AV-1 1000 mg on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single IV infusion (infusion duration: 1 hour) of placebo matched to AV-1 on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (29 listed)
- Any significant medical condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participating for that subject, based on the Investigator's Brochure and the safety profile of AV-1.
- Subject has one or more symptoms of a urinary tract infection (e.g. dysuria, frequent, urgency, or suprapubic pain) at Screening or Check-in.
- Has certain abnormal12-lead ECG (electrocardiogram) results according to the protocol, as assessed by the Investigator.
- Has abnormal laboratory values for certain hematology, serum chemistry, coagulation, or urinalysis tests according to the protocol, as assessed by the Investigator.
- Is positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody types 1 and 2 within 35 days of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-1Single dose, administered by IV infusion (volume: 250 mL) | Drug | AV-1 1000 mg, AV-1 250 mg, AV-1 30 mg, AV-1 500 mg, AV-1 90 mg |
| Placebo0.9% sterile saline. Administered by IV infusion (volume: 250 mL) | Drug | Placebo |
Primary outcome
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 120 (± 5 days)
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.
Number of Participants With Physical Examination Abnormalities Reported as TEAEs
Time frame: Baseline up to Day 120 (± 5 days)
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.
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Time frame: Baseline up to Day 120 (± 5 days)
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.
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities Reported as TEAEs
Time frame: Baseline up to Day 120 (± 5 days)
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.
Number of Participants With TEAEs
Time frame: Baseline up to Day 120 (± 5 days)
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.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 120 (± 5 days)
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: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect 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.
Number of Participants by Severity of AEs
Time frame: Baseline up to Day 120 (± 5 days)
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.
9 secondary outcomes
Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-infinity) of AV-1
Time frame: 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
AUC From Time 0 to 48 Hours Postdose (AUC0-48) of AV-1
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Days 29 (±2), 85 (±5), and 120 (±5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42253092Bouzidi 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.
- FDA Medical Product Safety InformationLink provided by the sponsor.
- FDA Recalls, Market Withdrawals, and Safety AlertsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Wood-Horrall, MD principal investigator
PPD Development, LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV-1 in people with Healthy Volunteers, run by AbViro LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 120 (± 5 days)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.