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

NCT01406418 | Completed Phase 1 DMC

• 2 other identifiers: FLU-M6-C001DMID Protocol 11-0025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

Influenza; Virus; Monoclonal; Antibody; Immunization; Treatment

Outcome Measures

Primary Outcomes (1)

• Adverse events and changes in laboratory parameters and vital signs as measures of safety and tolerability of single escalating doses of CR6261

  From baseline to 75 days post-dose

Secondary Outcomes (2)

• Assessment of pharmacokinetics of single escalating doses of CR6261

  From baseline to 75 days post-dose

• Assessment of antibodies binding to CR6261 as a measure of immunogenicity of single escalating doses of CR6261

  From baseline to 75 days post-dose

Study Arms (12)

Cohort 1: CR6261

EXPERIMENTAL

2 mg/kg CR6261

Biological: CR6261 2 mg/kg

Cohort 1: Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 2: CR6261

EXPERIMENTAL

5 mg/kg CR6261

Biological: CR6261 5 mg/kg

Cohort 2: Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 3: CR6261

EXPERIMENTAL

15 mg/kg CR6261

Biological: CR6261 15 mg/kg

Cohort 3: Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 4: CR6261

EXPERIMENTAL

30 mg/kg CR6261

Biological: CR6261 30 mg/kg

Cohort 4: Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 5: CR6261

EXPERIMENTAL

50 mg/kg CR6261

Biological: CR6261 50 mg/kg

Cohort 5: Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 6: CR6261

EXPERIMENTAL

30 mg/kg CR6261

Biological: CR6261 30 mg/kg

Cohort 6 Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Interventions

CR6261 2 mg/kg BIOLOGICAL

Administered as a single 2-hour intravenous infusion

Cohort 1: CR6261

CR6261 5 mg/kg BIOLOGICAL

Administered as a single 2-hour intravenous infusion

Cohort 2: CR6261

CR6261 15 mg/kg BIOLOGICAL

Administered as a single 2-hour intravenous infusion

Cohort 3: CR6261

CR6261 30 mg/kg BIOLOGICAL

Administered as a single 2-hour intravenous infusion

Cohort 4: CR6261; Cohort 6: CR6261

CR6261 50 mg/kg BIOLOGICAL

Administered as a single 2-hour intravenous infusion

Cohort 5: CR6261

Placebo BIOLOGICAL

Administered as a single 2-hour intravenous infusion

Cohort 1: Placebo; Cohort 2: Placebo; Cohort 3: Placebo; Cohort 4: Placebo; Cohort 5: Placebo; Cohort 6 Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Crucell Holland BV: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Quintiles Early Clinical Development

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Officials

• Eleanor Lisbon, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 1, 2011
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

US (1)