Trial reportClinical pharmacokinetics2018
Pharmacokinetics of MHAA4549A, an Anti-Influenza A Monoclonal Antibody, in Healthy Subjects Challenged with Influenza A Virus in a Phase IIa Randomized Trial.
Trial report in Clinical pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01980966 (A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study in Healthy Volunteers to Evaluate the Efficacy and Safety of MHAA4549A in an Influenza Challenge Model), which is not on this map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study in Healthy Volunteers to Evaluate the Efficacy and Safety of MHAA4549A in an Influenza Challenge Model
Who cites it
19 citing papers in PubMed, 31 citations in OpenAlex.
- Prophylactic Efficacy of CD388, a Novel Drug-Fc Conjugate, in a Human Influenza A/H3N2 Virus Challenge Model: A Randomized, Controlled Phase 2a Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Pharmacokinetics of the Monoclonal Antibody MHAA4549A Administered in Combination With Oseltamivir in Patients Hospitalized With Severe Influenza A Infection.Journal of clinical pharmacology · 2020Trial
- Evaluation of MEDI8852, an Anti-Influenza A Monoclonal Antibody, in Treating Acute Uncomplicated Influenza.Antimicrobial agents and chemotherapy · 2018Trial
- Phase 2 Randomized Trial of the Safety and Efficacy of MHAA4549A, a Broadly Neutralizing Monoclonal Antibody, in a Human Influenza A Virus Challenge Model.Antimicrobial agents and chemotherapy · 2017Trial
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers.Antimicrobial agents and chemotherapy · 2017Trial
- Passive Immunization in the Prevention and Treatment of Viral Infections.European journal of immunology · 2025Review
- Monoclonal Antibodies and Hyperimmune Immunoglobulins in the Next Pandemic.Current topics in microbiology and immunology · 2025Review
- A Trapping-Micro-LC-FAIMS/dCV-MS Strategy for Ultrasensitive and Robust Targeted Quantification of Protein Drugs and Biomarkers.Analytical chemistry · 2024Article
- Latest developments in early diagnosis and specific treatment of severe influenza infection.Journal of intensive medicine · 2024Review
- Antiviral options and therapeutics against influenza: history, latest developments and future prospects.Frontiers in cellular and infection microbiology · 2023Review
- Physiologically-based pharmacokinetic model for pulmonary disposition of protein therapeutics in humans.Journal of pharmacokinetics and pharmacodynamics · 2022Article
- Preclinical and clinical developments for combination treatment of influenza.PLoS pathogens · 2022Review
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of the Monoclonal Antibody MHAA4549A in Patients With Acute Uncomplicated Influenza A Infection.Open forum infectious diseases · 2022Article
- Protective porcine influenza virus-specific monoclonal antibodies recognize similar haemagglutinin epitopes as humans.PLoS pathogens · 2021Article
- Advances in the development of entry inhibitors for sialic-acid-targeting viruses.Drug discovery today · 2021Review
- Establishment of a Pig Influenza Challenge Model for Evaluation of Monoclonal Antibody Delivery Platforms.Journal of immunology (Baltimore, Md. : 1950) · 2020Article
- Overview of Current Therapeutics and Novel Candidates Against Influenza, Respiratory Syncytial Virus, and Middle East Respiratory Syndrome Coronavirus Infections.Frontiers in microbiology · 2019Review
- Prevention and treatment of respiratory viral infections: Presentations on antivirals, traditional therapies and host-directed interventions at the 5th ISIRV Antiviral Group conference.Antiviral research · 2018Article
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesMHAA4549A, a human anti-influenza immunoglobulin (Ig) G1 monoclonal antibody, is being developed to treat patients hospitalized for influenza A infection. This study examined the pharmacokinetics (PKs) of MHAA4549A in a phase IIa, randomized, double-blind, dose-ranging trial in healthy volunteers challenged with influenza A virus.
methodsSerum PK data were collected from 60 subjects in three single-dose groups (400, 1200, or 3600 mg) who received MHAA4549A intravenously 24-36 h after inoculation with the influenza A virus. Nasopharyngeal swab MHAA4549A concentration data were collected on days 1-8, and all subjects, including the placebo group, received 75 mg oseltamivir twice daily from days 7 to 11. Plasma samples were collected 4 h postdose on day 8 for oseltamivir and its active metabolite oseltamivir carboxylate (OC) (all subjects, n = 100), including subjects treated with oseltamivir alone and placebo. Noncompartmental analysis was performed for both nasal and serum PKs.
resultsMHAA4549A showed dose-proportional serum PKs with a long terminal half-life (approximately 21.9-24.6 days) and slow clearance (approximately 152-240 mL/day); however, nasopharyngeal swab PKs were not dose proportional. No differences in mean plasma concentrations of oseltamivir and OC at 4 h postdose on day 8 were observed between the MHAA4549A treatment and placebo groups. No subjects who received MHAA4549A developed anti-drug antibodies.
conclusionMHAA4549A serum PKs were consistent with that of a human IgG1antibody without known endogenous targets. MHAA4549A showed nonlinear PKs in nasopharyngeal swab samples, which will guide future dose selection to achieve the high drug concentrations needed at the site of action for efficacy. These data demonstrate no PK interactions between MHAA4549A and oseltamivir, and support flat dosing.
trial registrationClinicalTrials.gov identifier, NCT01980966.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.