Phase 2
N=124
A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
Influenza A
Bottom Line
View on ClinicalTrials.gov: NCT02623322 ↗Enrolled (actual)
124
Serious AEs
0.8%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Participants With Adverse Events (AEs) — 30.2; 39.0; 30.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MHAA4549A (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
30.2; 39.0; 30.0 | — |
| SECONDARY Percentage of Participants Requiring Hospitalization for Influenza-Related Complications |
0; 0; 0 | — |
| SECONDARY Duration of Hospitalization for Influenza-Related Complications |
0; 0; 0 | — |
| SECONDARY Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections |
3.0; 0; 0 | 0.3031 |
| SECONDARY Percentage of Participants With Complications of Influenza |
3.0; 0; 0 | 0.3031 |
| SECONDARY Percentage of Participants With Influenza A Relapse/Reinfection |
0; 0; 0 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) of MHAA4549A |
— | — |
| SECONDARY Maximum Serum Concentration (Cmax) of MHAA4549A |
1050; 2190 | — |
| SECONDARY Time to Alleviation of Symptoms of Influenza A Infection |
117.30; 153.80; 145.82; 44.50; 74.18; 65.59 | 0.7858 |
| SECONDARY Percentage of Participants With Influenza-Related Deaths |
0; 0; 0 | — |
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.
Eligibility Criteria
Inclusion Criteria
- Otherwise healthy participants
- Positive test for influenza A infection
- No more than 72 hours elapsed between onset of influenza-like illness and start of study drug
- Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea
- For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration
- For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration
Exclusion Criteria
- Creatinine clearance less than or equal to (</=) 80 milliliters per minute (mL/min)
- Any significant medical conditions or laboratory abnormalities
- Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection
- Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrollment
- Pregnancy at Screening or is currently pregnant or breastfeeding
- Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater
- Prior anti-influenza monoclonal antibody use
- Receipt of a nasal influenza A vaccine within 14 days prior to Screening
- Positive test for influenza B or influenza A+B within 2 weeks prior to study drug
- History of significant tobacco use or drug/alcohol abuse
- Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening
- Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications
- History of any chronic respiratory condition
- Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count </= 200 cells per milliliter (cells/mL) in the past 12 months
- Serious infection requiring oral or IV antibiotics within 14 days prior to Screening
Data sourced from ClinicalTrials.gov (NCT02623322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.