InfluenzaPhase 1NCT01406418

Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus

A Phase 1 study testing CR6261 2 mg/kg, CR6261 5 mg/kg and CR6261 15 mg/kg in people with Influenza, run by Crucell Holland BV at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal antibody against influenza A viruses. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: CR6261 2 mg/kg, CR6261 5 mg/kg and CR6261 15 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Nov 2013
Phase: Phase 1
Are there results?: None posted in the registry

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adult male and female subjects aged 18 to 50 years on Study Day 1.
Body mass index between 18 and 30 (kg/m2) by nomogram or calculation; body weight between 50 kg and 100 kg.
Has acceptable blood pressure and heart rate parameters within the normal limits (systolic = 88-140 mmHg; diastolic = 50 to <90 mmHg; heart rate = 46 to 100 bpm).
Healthy as determined by pre-study medical history, physical examination, and laboratory assessments.
Able and willing to give written informed consent.
Has the ability to complete the follow-up period of 75 days as required by the protocol.

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Subjects must agree to abstain from alcohol intake 24 hours before administration of study drug, during the inpatient period of the study and 24 hours prior to all other outpatient clinic visits.
Subjects must agree to not use OTC medications (including aspirin, decongestants, antihistamines and other NSAIDs), and herbal medication (including, but not limited to, herbal tea, St. John's Wort), within 14 days prior to study drug administration through the final follow-up visit, unless approved by the investigator and medical monitor. Occasional use of acetaminophen/paracetamol at recommended doses (≤ 1 gram/6 hours and ≤ 4 grams/day) and continued pre-existing use of vitamins or multivitamins at recommended doses is allowed.
Female subjects must:
Be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
If heterosexually active, use two effective methods of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, contraceptive ring, intrauterine device, barrier method (e.g. condoms, diaphragm, or cervical cap), or spermicidal foam, cream, or gel), or
Confirm male partner sterilization, or
Not be heterosexually active Note: women who are not heterosexually active at screening must agree to utilize two effective methods of birth control if they become heterosexually active during their participation in the study.
Women must agree to continue using these methods of contraception throughout the study.
Females must have a negative urine pregnancy test at both screening and baseline.
If a man who is able to father a child and sexually active with a female of childbearing potential, he must agree to use a double barrier method of birth control (e.g. condom with spermicidal foam, cream, or gel) and to not donate sperm during the study.
Subjects must agree to avoid strenuous exercise (e.g. long distance running >5 km/day, weight lifting, or any physical activity to which the subject is not accustomed) while confined to the Clinical Unit and for at least 72 hours prior to study drug administration and follow up visits.

Who cannot join

Acute illness at the time of entry into the study (Study Day 1).
Temperature >99.5oF (37.5oC) at randomization.
Presence of a significant infection or known inflammatory process during screening or at the time of randomization.
Presence of acute gastrointestinal symptoms during screening or at the time of randomization (e.g. nausea, vomiting, diarrhea, or heartburn).
A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection (e.g. fever, myalgias, headache, fatigue, non-productive cough, sore throat, and/or rhinorrhea) within 14 days prior to Study Day 1.
Received any live virus or bacterial vaccinations within 3 months prior to screening or are expected to receive any live virus or bacterial vaccinations during the study.

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Received inactivated influenza vaccines within 2 weeks of Study Day 1 or are expected to receive an inactivated influenza vaccine during the study.
Any chronic condition requiring prescription or over-the-counter medicine, with the exception of vitamins.
Chronic (longer than 14 days) administration of immunosuppressants or other immune modifying drugs within 6 months before administration of the investigational product; oral corticosteroids in dosages of < 0.5 mg/kg/d prednisolone or equivalent and inhaled/nasally/topically administered corticosteroids are permitted.
Antibiotic therapy within 7 days before Study Day 1.
History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders, which, in the opinion of the Principal Investigator may either put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
Previous medical history that may compromise the safety of the subject in the study.
Positive serology for the human immunodeficiency virus (HIV) 1 or 2 antibody, hepatitis C virus antibody or hepatitis B surface antigen.
History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
Known or suspected hypersensitivity to any CR6261 excipients (Sucrose, L-Histidine L-Histidine Monohydrochloride, Polysorbate 20).
A history of alcohol or drug abuse within the past 2 years as according to DSM IV.
Positive urine test for illicit drugs (opiates, cocaine, amphetamines) during screening and admission (Day -1).
Subjects who report current tobacco use of more than 10 cigarettes or 2 cigars per day at screening or anticipate use exceeding this amount at any time during the study.
Receipt of any other investigational product within 1 month or 5 half-lives (whichever is longer) before administration of the study investigational product.
Participation in any clinical study involving receipt of investigational product, blood or blood products, or donation of blood throughout the duration of the study.
Received antibody or biologic therapy (e.g. Ig products, mAbs, or antibody fragments).
Subjects who have donated and/or received any blood or blood products within 3 months before administration of the study investigational product or planned donation/receipt throughout the course of the study.
Subjects who cannot communicate reliably with the investigator.
Any condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
Employee at the clinic, or spouse/relative of the investigator or employees.
Has experienced an anaphylactic reaction to latex.
Have currently or a past history of thrombocytopenia or bleeding abnormality.
Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
Female subjects who are breastfeeding.
Drinks more than 1200 mL (or 5 cups of 240 mL per cup) of tea/coffee/cocoa/cola or other caffeinated beverage per day more than one day per week in the 2 weeks before screening.
ECG findings (Screening or Day-1):
QTc interval >450 msec;
evidence of second- or third-degree atrioventricular (AV) block;
pathological Q-waves (defined as Q-wave >40 msec or depth greater than 0.4 - 0.5 mV);
evidence of ventricular pre-excitation;
electrocardiographic evidence of complete left bundle branch block, right bundle branch block (RBBB), incomplete LBBB;
intraventricular conduction delay with QRS duration >120 msec.
Laboratory assessments (Screening or Day -1):
Hemoglobin below the lower limit of normal (LLN); a lower limit of 13.6 g/dL in males is acceptable;
Platelet count, absolute neutrophil count (ANC), or absolute lymphocyte count below LLN (ANC of 1.3 x 10³/µL is acceptable lower limit for African Americans);
White blood cell count above the upper limit of normal (ULN) or below the LLN (3.2 x 10³/µL is acceptable lower limit for African Americans);
Creatinine above the ULN;
PT or PTT above the ULN;
ALT, AST, GGTP, ALP, amylase, lipase, or total bilirubin ≥ 1.1 times the ULN (values below the LLN are not considered clinically significant).

Trial locations and contacts

1 site in 1 country.

United States1 site

Quintiles Early Clinical Development
Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CR6261, a Monoclonal Antibody Against Influenza A Viruses, Following Single-Dose Intravenous Administration

Read the detailed description

This randomized, double-blind, placebo-controlled dose escalation study will enroll up to 6 cohorts of healthy subjects. Eight subjects will be enrolled in each cohort (1 to 5) and will receive a single 2-hour intravenous infusion of CR6261 (6 subjects) or placebo (2 subjects) on Day 1. Subjects will be dosed in pairs of two. Once all subjects in a cohort have completed Study Day 8, the preliminary safety data will be reviewed. Provided that no safety issues are identified, dose escalation to the subsequent cohort may be permitted.

To obtain additional data at the 30 mg/kg dose level, a sixth cohort will be enrolled after the preliminary safety and tolerability of the 30 mg/kg dose in Cohort 4 is demonstrated. Cohort 6 will be comprised of 24 subjects (randomized 5 : 1 to CR6261 or placebo) following the same visit schedule as subjects in Cohorts 1-5.

Conditions: Influenza
Being tested: CR6261 2 mg/kg, CR6261 5 mg/kg, CR6261 15 mg/kg, CR6261 30 mg/kg, CR6261 50 mg/kg
Keywords: Influenza, Virus, Monoclonal, Antibody, Immunization, Treatment
Medical subject headings: Influenza, Human, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CR6261 2 mg/kgBiological
Administered as a single 2-hour intravenous infusion
CR6261 5 mg/kgBiological
Administered as a single 2-hour intravenous infusion
CR6261 15 mg/kgBiological
Administered as a single 2-hour intravenous infusion
CR6261 30 mg/kgBiological
Administered as a single 2-hour intravenous infusion
CR6261 50 mg/kgBiological
Administered as a single 2-hour intravenous infusion
PlaceboBiological
Administered as a single 2-hour intravenous infusion

Study groups in NCT01406418
Study group	Role	What they receive
Cohort 1: CR6261	Experimental	2 mg/kg CR6261 Receives: Biological: CR6261 2 mg/kg
Cohort 1: Placebo	Placebo comparator	5% dextrose in water Receives: Biological: Placebo
Cohort 2: CR6261	Experimental	5 mg/kg CR6261 Receives: Biological: CR6261 5 mg/kg
Cohort 2: Placebo	Placebo comparator	5% dextrose in water Receives: Biological: Placebo
Cohort 3: CR6261	Experimental	15 mg/kg CR6261 Receives: Biological: CR6261 15 mg/kg
Cohort 3: Placebo	Placebo comparator	5% dextrose in water Receives: Biological: Placebo
Cohort 4: CR6261	Experimental	30 mg/kg CR6261 Receives: Biological: CR6261 30 mg/kg
Cohort 4: Placebo	Placebo comparator	5% dextrose in water Receives: Biological: Placebo
Cohort 5: CR6261	Experimental	50 mg/kg CR6261 Receives: Biological: CR6261 50 mg/kg
Cohort 5: Placebo	Placebo comparator	5% dextrose in water Receives: Biological: Placebo
Cohort 6: CR6261	Experimental	30 mg/kg CR6261 Receives: Biological: CR6261 30 mg/kg
Cohort 6 Placebo	Placebo comparator	5% dextrose in water Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events and changes in laboratory parameters and vital signs as measures of safety and tolerability of single escalating doses of CR6261
Measured: From baseline to 75 days post-dose

Secondary outcomes (2)

Assessment of pharmacokinetics of single escalating doses of CR6261
Pharmacokinetic parameters include area under the serum concentration-time curve from zero to the time of the last measurable concentration (AUC0-t), area under the serum concentration-time curve from zero to infinity (AUC0-inf), maximum concentration (Cmax), time of Cmax (tmax), systemic clearance (CL), terminal elimination half life (t1/2), etc.
Measured: From baseline to 75 days post-dose
Assessment of antibodies binding to CR6261 as a measure of immunogenicity of single escalating doses of CR6261
Measured: From baseline to 75 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Nov 2013

First posted1 Aug 2011 (estimated)
Study startFeb 2013
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfluenzaStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01406418
Sponsor's protocol ID: FLU-M6-C001
Other IDs: DMID Protocol 11-0025
Status last verified: Dec 2013
First submitted: 28 Jul 2011
Last updated: 19 Dec 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CR6261, a Monoclonal Antibody Against Influenza A Viruses, Following Single-Dose Intravenous Administration
ClinicalTrials.gov ID: NCT01406418
Acronym / sponsor ID: FLU-M6-C001
Conditions: Influenza
Keywords: Influenza, Virus, Monoclonal, Antibody, Immunization, Treatment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Feb 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 1 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
Cohort 1: CR6261	Experimental	Biological: CR6261 2 mg/kg2 mg/kg CR6261
Cohort 1: Placebo	Placebo comparator	Biological: Placebo5% dextrose in water
Cohort 2: CR6261	Experimental	Biological: CR6261 5 mg/kg5 mg/kg CR6261
Cohort 2: Placebo	Placebo comparator	Biological: Placebo5% dextrose in water
Cohort 3: CR6261	Experimental	Biological: CR6261 15 mg/kg15 mg/kg CR6261
Cohort 3: Placebo	Placebo comparator	Biological: Placebo5% dextrose in water
Cohort 4: CR6261	Experimental	Biological: CR6261 30 mg/kg30 mg/kg CR6261
Cohort 4: Placebo	Placebo comparator	Biological: Placebo5% dextrose in water
Cohort 5: CR6261	Experimental	Biological: CR6261 50 mg/kg50 mg/kg CR6261
Cohort 5: Placebo	Placebo comparator	Biological: Placebo5% dextrose in water
Cohort 6: CR6261	Experimental	Biological: CR6261 30 mg/kg30 mg/kg CR6261
Cohort 6 Placebo	Placebo comparator	Biological: Placebo5% dextrose in water

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Adult male and female subjects aged 18 to 50 years on Study Day 1.
Body mass index between 18 and 30 (kg/m2) by nomogram or calculation; body weight between 50 kg and 100 kg.
Has acceptable blood pressure and heart rate parameters within the normal limits (systolic = 88-140 mmHg; diastolic = 50 to <90 mmHg; heart rate = 46 to 100 bpm).
Healthy as determined by pre-study medical history, physical examination, and laboratory assessments.
Able and willing to give written informed consent.

Key exclusion criteria (44 listed)

Acute illness at the time of entry into the study (Study Day 1).
Temperature >99.5oF (37.5oC) at randomization.
Presence of a significant infection or known inflammatory process during screening or at the time of randomization.
Presence of acute gastrointestinal symptoms during screening or at the time of randomization (e.g. nausea, vomiting, diarrhea, or heartburn).
A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection (e.g. fever, myalgias, headache, fatigue, non-productive cough, sore throat, and/or rhinorrhea) within 14 days prior to Study Day 1.

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
CR6261 2 mg/kgAdministered as a single 2-hour intravenous infusion	Biological	Cohort 1: CR6261
CR6261 5 mg/kgAdministered as a single 2-hour intravenous infusion	Biological	Cohort 2: CR6261
CR6261 15 mg/kgAdministered as a single 2-hour intravenous infusion	Biological	Cohort 3: CR6261
CR6261 30 mg/kgAdministered as a single 2-hour intravenous infusion	Biological	Cohort 4: CR6261, Cohort 6: CR6261
CR6261 50 mg/kgAdministered as a single 2-hour intravenous infusion	Biological	Cohort 5: CR6261
PlaceboAdministered as a single 2-hour intravenous infusion	Biological	Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo, Cohort 5: Placebo, Cohort 6 Placebo

Primary outcome

Adverse events and changes in laboratory parameters and vital signs as measures of safety and tolerability of single escalating doses of CR6261
Time frame: From baseline to 75 days post-dose

2 secondary outcomes

Assessment of pharmacokinetics of single escalating doses of CR6261
Time frame: From baseline to 75 days post-dose
Assessment of antibodies binding to CR6261 as a measure of immunogenicity of single escalating doses of CR6261
Time frame: From baseline to 75 days post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.

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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.

Eleanor Lisbon, MD principal investigator

Quintiles, Inc.

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 CR6261 2 mg/kg, CR6261 5 mg/kg and CR6261 15 mg/kg in people with Influenza, run by Crucell Holland BV 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 17 inclusion and 44 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 19 Dec 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events and changes in laboratory parameters and vital signs as measures of safety and tolerability of single escalating doses of CR6261 (time frame: From baseline to 75 days post-dose). 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 NCT01406418.

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 19 Dec 2013.