A Study to Evaluate the Safety and Efficacy of AV-1 Against Dengue Virus 3 (DENV-3) Infection

NCT06799741 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AV1-PPD-0006
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to determine the prophylactic and therapeutic effect of AV-1 in healthy adults using a DENV-3 controlled human infection model (CHIM)

Conditions

DENV-3 Controlled Human Infection Model

Keywords

Healthy Volunteers; Monoclonal antibody; AV-1; Safety; Dengue; Efficacy

Outcome Measures

Primary Outcomes (14)

• Incidence of Adverse Events (AEs)

  Defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related

  Through day 155 (±7 days)

• Severity of AEs

  Through day 155 (±7 days)

• Incidence of Serious Adverse Events (SAEs)

  Defined as an AE that is unexpected and serious as determined by the Sponsor

  Through day 155 (±7 days)

• Severity of SAEs

  Through day 155 (±7 days)

• Anti-AV-1 antibodies (ADA) Immunogenicity Testing

  Through day 155 (±7 days)

• Frequency of viremia

  Detected by direct serum titration

  Through day 155 (±7 days)

• Duration of viremia

  Defined as the time from the first infection to the time of the last infection

  Through day 155 (±7 days)

• Viral load

  Measured by qRT-PCR

  Through day 155 (±7 days)

• Viral load

  Measured by plaque assay

  Through day 155 (±7 days)

• Change from baseline values of diastolic blood pressure

  Through day 155 (±7 days)

• Change from baseline values of systolic blood pressure

  Through day 155 (±7 days)

• Change in baseline values of temperature

  Through day 155 (±7 days)

• Change in baseline values of respiration rate

  Through day 155 (±7 days)

• Change in baseline values of heart rate

  Through day 155 (±7 days)

Secondary Outcomes (13)

• Number of participants with detectable DENV-specific IgM antibodies

  Baseline through day 155 (±7 days)

• Percentage of participants with detectable DENV-specific IgM antibodies

  Baseline through day 155 (±7 days)

• Number of participants with detectable anti-DENV NS1 IgG antibodies

  Baseline through day 155 (±7 days)

• Percentage of participants with detectable anti-DENV NS1 IgG antibodies

  Baseline through day 155 (±7 days)

• Measure AV-1 concentration in human serum by anti-idiotype enzyme-linked immunosorbent assay (ELISA)

  Through day 155 (±7 days)

Study Arms (6)

Group 1A prophylaxis

EXPERIMENTAL

Drug: AV-1 100 mg; Drug: Placebo

Group 2A prophylaxis

EXPERIMENTAL

Drug: AV-1 300 mg; Drug: Placebo

Group 3A prophylaxis

EXPERIMENTAL

Drug: AV-1 900 mg; Drug: Placebo

Group 1B treatment

EXPERIMENTAL

Drug: AV-1 100 mg; Drug: Placebo

Group 2B treatment

EXPERIMENTAL

Drug: AV-1 300 mg; Drug: Placebo

Group 3B treatment

EXPERIMENTAL

Drug: AV-1 900 mg; Drug: Placebo

Interventions

AV-1 100 mg DRUG

human monoclonal antibody (mAb) intravenous solution or

Group 1A prophylaxis; Group 1B treatment

AV-1 300 mg DRUG

human monoclonal antibody (mAb) intravenous solution or

Group 2A prophylaxis; Group 2B treatment

AV-1 900 mg DRUG

human monoclonal antibody (mAb) intravenous solution or

Group 3A prophylaxis; Group 3B treatment

Placebo DRUG

(0.9% saline intravenous solution) 12:2

Group 1A prophylaxis; Group 1B treatment; Group 2A prophylaxis; Group 2B treatment; Group 3A prophylaxis; Group 3B treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or nonpregnant, nonlactating females who were assigned males and females at birth, of any race, between 18 and 55 years of age
• Body mass index between 18.5 and 34.9 kg/m², inclusive, at Screening or Study Day -1 (Cohort A) or Study Day 0 (Cohort B)
• Normal 12-lead electrocardiogram (ECG). Normal ECG is defined as the absence of:
• QTcF \>450 ms in men or \>460 ms in women
• PR \>220 ms ventricular or atrial premature contractions in couplets or higher in grouping
• Complete left or right bundle branch block
• nd or 3rd degree atrioventricular block
• Sustained ventricular or atrial arrhythmia
• ST elevation consistent with cardiac ischemia
• Potential subjects with non-clinical sinus arrhythmia could be included in the study
• Subjects in good health as determined by past medical history, medication use, physical examination, vital signs, and 12-lead ECG at Screening
• Females of childbearing potential must agree to use effective contraception through study duration
• Reliable methods of contraception include: long acting, reversible contraception (LARC), hormonal birth control\* (implantable device, hormonal patch, hormonal vaginal ring, oral contraception, Depo-Provera injection, etc.), surgical sterilization (hysterectomy, tubal ligation, or tubal coil at least 90 days prior to Investigational Product \[IP\] dosing)
• Must agree to not donate ova or oocytes during the study
• Postmenopausal women must have had ≥12 months of spontaneous amenorrhea without an alternative medical cause for amenorrhea, with follicle-stimulating hormone (FSH) concentration ≥40 mIU/mL at Screening and must have a negative pregnancy test result at Screening and Day-1 (Cohort A) or Day 0 (Cohort B)

You may not qualify if:

• Any significant medical condition who, in the opinion of the investigator, would interfere with the ability to participate in the study or increase the risk of participating for that subject based on the Investigator's Brochures and the safety profiles of AV-1 and rDEN3Δ30
• 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 the participation for that subject
• History of significant alcoholism or drug/chemical abuse within 12 months prior to Study Day -1 that has caused medical, occupational, or family problems as indicated by subject history
• Currently being treated for peptic ulcer disease or Helicobacter pylori or has been treated within the 6 months prior to Day -1
• History of or suspected coagulopathy
• Alcohol consumption of \>21 units\* per week for males and \>14 units per week for females (\*1 unit of alcohol equals 12 oz \[360 mL\] beer, 1.5 oz \[45 mL\] liquor, or 5 oz \[150 mL\] wine) through Study Day 28
• Positive urine drug screen at Screening for drugs of abuse defined as Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolite, Opiates, Oxycodone, Phencyclidine without confirmation of medical need verified by prescription (ie, anxiolytics or pain medications).
• Women with positive pregnancy test at either Screening visit, Study Day -1, or Study Day 0
• Seropositive for Hepatitis B surface antigen (HBsAg) or positive for Hepatitis C RNA at Screening
• 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
• Plan to travel to an area with active Zika virus (ZIKV) or DENV, transmission during the study or returned from travel to an area with active transmission within 30 days of Screening. (\*Refer to the Centers for Disease Control and Prevention \[CDC\] website for areas with active ZIKV or DENV)
• History of vaccination with a licensed or investigational ZIKV vaccine, DENV vaccine\*, yellow fever virus (YFV) vaccine, or Japanese encephalitis vaccine or reportedly diagnosed with a ZIKV or DENV infection or disease. (\*Includes subject's verbal history of vaccination or disease).
• Positive serology to DENV, ZIKV, West Nile virus (WNV), YFV, or St. Louis encephalitis virus (SLE) within 60 days of Screening
• History of anaphylaxis to any drug compound, (including citrate or polysorbate), food, or other substance, unless approved by the investigator
• Major non-elective surgery within the last 3 months

Sponsors & Collaborators

• AbViro LLC: lead

Study Sites (3)

Center for Immunization Research (CIR) JHBSPH

Baltimore, Maryland, 21205, United States

Location

Center for Immunization Research Inpatient Unit

Baltimore, Maryland, 21224, United States

Location

UVM Larner College of Medicine Department of MMG

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Urban Ramstedt, PhD

  AbViro LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 29, 2025
• Study Start: January 7, 2025
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)