NCT01756950

Brief Summary

The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal antibody against influenza A viruses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

December 15, 2012

Last Update Submit

December 18, 2013

Conditions

Influenza

Keywords

InfluenzaVirusMonoclonalAntibodyImmunizationTreatment

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 CR8020

    From baseline to 98 days post-dose

Secondary Outcomes (2)

  • Assessment of pharmacokinetics of single escalating doses of CR8020

    From baseline to 98 days post-dose

  • Assessment of antibodies binding to CR8020 as a measure of immunogenicity of single escalating doses of CR8020

    From baseline to 98 days post-dose

Study Arms (12)

Cohort 1 - CR8020

EXPERIMENTAL

2 mg/kg CR8020

Biological: 2 mg/kg CR8020

Cohort 1 - Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 2 - CR8020

EXPERIMENTAL

5 mg/kg CR8020

Biological: 5 mg/kg CR8020

Cohort 2 - Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 3 - CR8020

EXPERIMENTAL

15 mg/kg CR8020

Biological: 15 mg/kg CR8020

Cohort 3 - Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 4 - CR8020

EXPERIMENTAL

30 mg/kg CR8020

Biological: 30 mg/kg CR8020

Cohort 4 - Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 5 - CR8020

EXPERIMENTAL

50 mg/kg CR8020

Biological: 50 mg/kg CR8020

Cohort 5 - Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Cohort 6 - CR8020

EXPERIMENTAL

30 mg/kg CR8020

Biological: 30 mg/kg CR8020

Cohort 6 - Placebo

PLACEBO COMPARATOR

5% dextrose in water

Biological: Placebo

Interventions

2 mg/kg CR8020BIOLOGICAL

administered as a single 2-hour intravenous infusion

Cohort 1 - CR8020
5 mg/kg CR8020BIOLOGICAL

administered as a single 2-hour intravenous infusion

Cohort 2 - CR8020
15 mg/kg CR8020BIOLOGICAL

administered as a single 2-hour intravenous infusion

Cohort 3 - CR8020
30 mg/kg CR8020BIOLOGICAL

administered as a single 2-hour intravenous infusion

Cohort 4 - CR8020Cohort 6 - CR8020
50 mg/kg CR8020BIOLOGICAL

administered as a single 2-hour intravenous infusion

Cohort 5 - CR8020
PlaceboBIOLOGICAL

administered as a single 2-hour intravenous infusion

Cohort 1 - PlaceboCohort 2 - PlaceboCohort 3 - PlaceboCohort 4 - PlaceboCohort 5 - PlaceboCohort 6 - Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 to100 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 as required by the protocol.
  • Subjects must agree to abstain from alcohol intake 24 hours before administration of study drug, during the inpatient period(s) 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.
  • +2 more criteria

You may not qualify if:

  • Acute illness at the time of entry into the study (Study Day 1).
  • Temperature \>99.5 °F (37.5 °C) 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/day 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 CR8020 excipients (sucrose, L-histidine L-histidine monohydrochloride, polysorbate 20).
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles Early Clinical Development

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Influenza, HumanVirus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsRespiratory Tract Diseases

Study Officials

  • David R Mathews, 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

December 15, 2012

First Posted

December 28, 2012

Study Start

January 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)