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Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model
Phase 2 trial testing CR6261 in H1N1 Influenza Healthy Volunteers in 104 participants. Completed in 30 November 2018.
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 104 |
| Start date | 25 February 2015 |
| Primary completion | 30 November 2018 |
| Estimated completion | 30 November 2018 |
| Sites | 1 location across United States |
National Institute of Allergy and Infectious Diseases (NIAID)
Adults 18 to 45, any sex, with H1N1 Influenza Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area under the curve (AUC) calculated from quantitative real-time RT-PCR for influenza A taken from 3 time per day nasal swab collection.
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 48.56 | 8.00 – 209.68 |
| Placebo Comparator | 25.53 | 5.00 – 159.78 |
Percentage of participants who experienced either viral shedding or symptoms + a four fold rise in convalescent HAI titer.
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 73 | |
| Placebo Comparator | 88 |
Duration in days viral shedding was detected after influenza challenge
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 2 | 1 – 4 |
| Placebo Comparator | 2.5 | 1 – 5 |
Duration in days symptoms were experienced after influenza challenge
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 5 | 3 – 7 |
| Placebo Comparator | 6 | 5 – 7 |
Percentage of participants who experienced influenza symptoms and shedding
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 53 | |
| Placebo Comparator | 69 |
Number of unique influenza symptoms experienced after influenza challenge
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 3 | 2 – 5 |
| Placebo Comparator | 4 | 3 – 5 |
Percentage of participants who experienced influenza symptoms
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 76 | |
| Placebo Comparator | 93 |
Objective symptoms score from patient directed FLUPRO questionnaire (inFLUenza Patient-Reported Outcome dairy) . The FLUPRO questionnaire uses a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. Total scores can range from 0 (symptom free) to 4 (maximum severity of symptoms). Daily scores (Day 0 - Day 8) are averaged to calculate a total score for each participant, then calculated the median total FLUPRO score for each arm.
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 0.038 | 0.0125 – 0.08438 |
| Placebo Comparator | 0.057 | 0.04063 – 0.08438 |
Percentage of participants who experienced influenza viral shedding
| Group | Value | 95% CI |
|---|---|---|
| CR6261 | 67 | |
| Placebo Comparator | 74 |
Time frame: 70 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CR6261 | Placebo Comparator |
|---|---|---|---|
| Alcohol poisoning | Injury, poisoning and procedural complications | — | — |
| Reaction | System | CR6261 | Placebo Comparator |
|---|---|---|---|
| Rhinitis | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| Haemoglobin decreased | Investigations | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Amylase increased | Investigations | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Lipase increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Chills | General disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Pyrexia | General disorders | — | — |
| Conjunctivitis | Infections and infestations | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Systolic hypertension | Vascular disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Hypoproteinaemia | Metabolism and nutrition disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Oxygen saturation abnormal | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Activated partial thromboplastin time prolonged | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| White blood cell count decreased | Investigations | — | — |
Most-reported serious reactions: Alcohol poisoning.
Data from ClinicalTrials.gov NCT02371668 adverse events section.
Background: \- Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms. Objective: \- To see if the drug CR6261 reduces flu disease in people treated with this drug versus a placebo. Eligibility: \- Healthy nonsmokers ages 18 45. Design: * Participants will be screened under a separate protocol. * Participants must use contraception or abstinence for several weeks before and after the study. They must have no alcohol for 1 day before each visit. Any medicine must be approved by the study doctor until after follow-up. * Participants will stay in a hospital isolation unit for at least 10 days. * They will have: * Medical history * Physical exam * Blood and urine tests * Heart and lung test * Tests for drugs and alcohol * Throughout their stay, participants will: * Be closely watched by a medical team * Have nasal washes and swabs several times a day * Participants will have the flu virus sprayed in each nostril. * The next day, participants will get either study drug or placebo through a soft plastic tube placed in a vein by needle. It will take 2 hours. They will not know which they get. * Participants can go home after 10 days if they test negative for the flu 2 days in a row. * Participants will have daily questionnaires at home and 2 follow-up visits over 2 months.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02371668.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing