Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge

NCT01938352 | Completed Phase 2

• 4 other identifiers: CR102595CRU-CS-001CR8020FLZ20022013-002185-39
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.

Conditions

Influenza

Keywords

Influenza; Virus; Monoclonal Antibody; Immunization; Treatment

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of viral load

  Measured from the nasopharyngeal mucosa (by qPCR) post influenza virus challenge

  Day 7

Study Arms (2)

CR8020

EXPERIMENTAL

CR8020 administered as a single 2-hour intravenous infusion

Biological: CR8020

Placebo

PLACEBO COMPARATOR

Placebo administered as a single 2-hour intravenous infusion

Biological: Placebo

Interventions

CR8020 BIOLOGICAL

CR8020 15 mg/kg, administered by intravenous infusion

CR8020

Placebo BIOLOGICAL

Placebo (hydrous dextrose in water for injection), administered by intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects ≥ 18 and ≤ 45 years of age.
• In good health, with no major medical conditions from medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.
• A total body weight ≥50 kg and a BMI of \>18. If the BMI is above 28 the subject may be included if the waist measurement is less than 94 cm (male), or less than 80 cm (female).
• (a) Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
• (b) In addition, male subjects must not donate sperm following discharge from Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
• (c) Female subjects must be either:
• Documented status as surgically sterile or post hysterectomy or-
• If of childbearing potential, must have a negative serum and urine pregnancy test at study specific screening and Day -4/-3 and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 96 (± 5 days) Follow-up Visit.
• Acceptable forms of effective contraception include:
• Established use of oral, injected or implanted hormonal methods of contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). \[For female subjects on the study, the vasectomised male partner should be the sole partner for that subject\].
• True abstinence: When this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
• An informed consent document signed and dated by the subject and Investigator.

You may not qualify if:

• Subjects who have a significant history of tobacco use at any time (≥ total 10 pack year history, e.g. one pack a day for 10 years)
• (a) Females who are pregnant or have been pregnant within six months prior to the study, or who have been breastfeeding within three months prior to screening. Females who have a positive pregnancy test at any point in the study will be withdrawn immediately.
• (b) Females intending to become pregnant within three months of administration of CR8020 or placebo or males with female partners intending to become pregnant within three months of administration of CR8020 or placebo
• Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator
• Eczema/Atopic Dermatitis: (Subjects with clinically mild eczema/atopic dermatitis may be included at the Investigator's discretion e.g. if there is no regular use of topical steroids, no eczema in cubital fossa)
• Psoriasis:(Subjects with active psoriasis affecting less than 5% of the body's surface area for the past five years can be included at the Investigator's discretion- (1% of the body area is roughly equivalent to the palm of the subject's hand). Patients with a history of completely resolved guttate psoriasis can be included)
• Psychiatric: (Subjects with a diagnosis of a single mild or moderate depressive episode two or more years ago, with good evidence of preceding stressors and which resolved within approximately three months (i.e. reactive depression), may be included at the Investigator's discretion)
• Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities on spirometry
• History or evidence of autoimmune disease or known immunodeficiency of any cause
• Subjects with any history of asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (See No. 7 for asthma)
• Asthma (A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Patients with a single episode of wheezing after age 12 (lasting less than eight weeks) can be included at the Investigator's discretion)
• Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test
• Any significant abnormality altering the anatomy of the nose or nasopharynx
• Any clinically significant history of epistaxis
• Any nasal or sinus surgery within six months of Viral Challenge

Sponsors & Collaborators

• Crucell Holland BV: lead
• Retroscreen Virology Ltd.: collaborator

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 5, 2013
• First Posted: September 10, 2013
• Study Start: October 2, 2013
• Primary Completion: January 22, 2014
• Study Completion: January 22, 2014
• Last Updated: April 12, 2019

Record last verified: 2019-03

Locations

GB (1)