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Trial record 1 of 1 for:    BITS7201A
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A Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of BITS7201A in Healthy Volunteers and Participants With Mild Atopic Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748642
First Posted: April 22, 2016
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
This randomized, observer-blinded, placebo-controlled, single and multiple ascending-dose study will be conducted in two parts to evaluate the safety, pharmacokinetics, and immunogenicity of BITS7201A. Part A will be an ascending, single-dose, sequential-group study where participants will be randomly assigned to active drug or placebo. Part B will be an ascending, multiple-dose, sequential-group study where participants will be randomized to active drug or placebo. Total length of the study is anticipated to be approximately 12 months.

Condition Intervention Phase
Mild Atopic Asthma Drug: BITS7201A Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Observer-Blinded, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenecity of BITS7201A in Healthy Volunteers and Patients With Mild Atopic Asthma

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to end of the study (Approximately 12 months) ]
  • Number of Participants with Anti-Therapeutic Antibodies (ATA) to BITS7201A and Associated Clinical Sequelae [ Time Frame: Baseline up to end of the study (Approximately 12 months) ]

Secondary Outcome Measures:
  • Maximum Observed Serum Concentration (Cmax) of BITS7201A [ Time Frame: Part A: predose on Day 1; Days 2, 5, 8, 15, 29, 43, 57, 85; 0.5, 2 hours postdose (for IV only) on Day 1; Part B: predose on Days 1, 29, 57; on Days 5, 8 15, 61, 71, 85, 113, 141 (predose: 0 hour; IV infusion duration = 15 approximately minutes) ]
  • Total Clearance (CL/F) of BITS7201A [ Time Frame: Part A: predose on Day 1; Days 2, 5, 8, 15, 29, 43, 57, 85; 0.5, 2 hours postdose (for IV only) on Day 1; Part B: predose on Days 1, 29, 57; on Days 5, 8 15, 61, 71, 85, 113, 141 (predose: 0 hour; IV infusion duration = 15 approximately minutes) ]
  • Apparent Volume of Distribution (Vz/F) of BITS7201A [ Time Frame: Part A: predose on Day 1; Days 2, 5, 8, 15, 29, 43, 57, 85; 0.5, 2 hours postdose (for IV only) on Day 1; Part B: predose on Days 1, 29, 57; on Days 5, 8 15, 61, 71, 85, 113, 141 (predose: 0 hour; IV infusion duration = 15 approximately minutes) ]
  • Area under the Concentration-Time Curve (AUC) of BITS7201A [ Time Frame: Part A: predose on Day 1; Days 2, 5, 8, 15, 29, 43, 57, 85; 0.5, 2 hours postdose (for IV only) on Day 1; Part B: predose on Days 1, 29, 57; on Days 5, 8 15, 61, 71, 85, 113, 141 (predose: 0 hour; IV infusion duration = 15 approximately minutes) ]
  • Half-Life (t1/2) of BITS7201A [ Time Frame: Part A: predose on Day 1; Days 2, 5, 8, 15, 29, 43, 57, 85; 0.5, 2 hours postdose (for IV only) on Day 1; Part B: predose on Days 1, 29, 57; on Days 5, 8 15, 61, 71, 85, 113, 141 (predose: 0 hour; IV infusion duration = 15 approximately minutes) ]
  • Bioavailability (Percentage of Administered Dose Reaching the Systemic Circulation) of BITS7201A [ Time Frame: Part A: predose on Day 1; Days 2, 5, 8, 15, 29, 43, 57, 85; 0.5, 2 hours postdose (for IV only) on Day 1; Part B: predose on Days 1, 29, 57; on Days 5, 8 15, 61, 71, 85, 113, 141 (predose: 0 hour; IV infusion duration = 15 approximately minutes) ]
  • Number of Participants with Impact of ATA Status [ Time Frame: Baseline up to end of the study (Approximately 12 months) ]

Enrollment: 67
Actual Study Start Date: April 7, 2016
Study Completion Date: June 14, 2017
Primary Completion Date: June 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A Cohort A: BITS7201A Dose Level 1 Subcutaneous (SC)
Healthy participants will receive a single SC dose of BITS7201A dose Level 1 on Day 1.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Experimental: Part A Cohort B: BITS7201A Dose Level 2 SC
Healthy participants will receive a single SC dose of BITS7201A dose Level 2 on Day 1.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Experimental: Part A Cohort C: BITS7201A Dose Level 4 SC
Healthy participants will receive a single SC dose of BITS7201A dose Level 4 on Day 1.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Experimental: Part A Cohort D: BITS7201A Dose Level 4 Intravenous (IV)
Healthy participants will receive a single IV dose of BITS7201A dose Level 4 on Day 1.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Experimental: Part A Cohort E: BITS7201A Dose Level 6 IV
Healthy participants will receive a single IV dose of BITS7201A dose Level 6 on Day 1.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Placebo Comparator: Part A: Placebo
Healthy participants will receive a single SC or IV dose of placebo matched to BITS7201A on Day 1.
Drug: Placebo
Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Experimental: Part B Cohort F: BITS7201A Dose Level 3 SC
Healthy participants will receive a single SC dose of BITS7201A dose Level 3 every 4 weeks (Q4W) on Days 1, 29, and 57.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Experimental: Part B Cohort G: BITS7201A Dose Level 4 SC
Healthy participants will receive a single SC dose of BITS7201A dose Level 4 Q4W on Days 1, 29, and 57.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Experimental: Part B Cohort H: BITS7201A Dose Level 5 SC
Healthy participants will receive SC dose of BITS7201A dose Level 5 Q4W on Days 1, 29, and 57.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Experimental: Part B Cohort I:BITS7201A Dose Level 5 SC (Mild Atopic Asthma)
Mild atopic asthma participants will receive SC dose of BITS7201 dose Level 5 Q4W on Days 1, 29, and 57.
Drug: BITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other Name: RO7040547
Placebo Comparator: Part B: Placebo
Healthy participants or mild atopic asthma participants will receive SC doses of placebo matched to BITS7201A Q4W on Days 1, 29, and 57.
Drug: Placebo
Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

General Inclusion Criteria:

  • Body mass index between 18 and 37 kilograms per meter square (kg/m^2)
  • Weight 50-120 kilograms
  • Participants in good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
  • Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the Investigator and Sponsor.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method for at least 70 days after the last dose of study drug
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm for at least 70 days after the last dose of study drug

Additional Inclusion Criteria for Participants With Mild Atopic Asthma:

  • Diagnosis of asthma for greater than or equal to (>/=) 3 months prior to screening
  • History of atopy
  • Pre-bronchodilator forced expiratory volume in 1 second (FEV1) >/=60 percent (%) predicted at screening
  • Fractional exhaled nitric oxide (FeNO) >/=30 parts per billion (ppb) at screening and at randomization (predose)

Exclusion Criteria:

General Exclusion Criteria:

  • History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
  • History of hematologic or immunosuppressive disorders
  • History of severe depression or suicidal ideation
  • History of inflammatory bowel disease
  • History of anaphylaxis, hypersensitivity, or significant drug allergies
  • History or presence of an abnormal ECG, which is clinically significant
  • History of a positive tuberculin skin test in participants who are Bacille Calmette-Guérin (BCG) vaccine naïve or history of a positive interferon-gamma release assay in participants who have received the BCG vaccine
  • Participants with neutropenia or thrombocytopenia
  • History of alcoholism or drug addiction within 1 year of screening
  • Self-reported history of smoking (tobacco, marijuana, or vaping) within the 7 days prior to initiation of study drug
  • Smokers not able to pass the tobacco-related laboratory screening and who cannot refrain from smoking during the confinement periods
  • Pregnancy or lactation
  • History of malignancy, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
  • Any severe bacterial, fungal, or parasitic infections associated with hospitalization or IV antibiotics within 1 year of screening
  • History of active parasitic infection within 6 months or exposure to water-born parasites within 6 weeks prior to initiation of study drug
  • Upper or lower respiratory tract infection within 4 weeks prior to screening
  • Received oral antibiotics within 4 weeks prior to initiation of study drug, or IV/intramuscular (IM) antibiotics within 8 weeks prior to initiation of study drug
  • For health volunteers: use of any prescription medications/products within 7 days prior to Day 1 and throughout the study
  • Use of any immunosuppressive medication within 30 days or 5 half-lives, whichever is greater, prior to initiation of study drug
  • Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to initiation of study drug (or within 5 half-lives of the investigational product, whichever is greater)
  • Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months or 5 half-lives, whichever is greater, prior to initiation of study drug
  • Received live or attenuated vaccine within 30 days prior to screening
  • Received killed vaccine within 14 days prior to initiation of study drug, unless deemed acceptable by the investigator and Sponsor
  • Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody

Additional Exclusion Criteria for Participants With Mild Atopic Asthma:

  • Poorly controlled asthma
  • Use of any prescription medications and/or products other than asthma and/or allergic rhinitis medications within 7 days prior to Day 1 and throughout the study, unless deemed acceptable by the investigator and Sponsor
  • Active lung disease other than asthma
  • Occupations with potential exposure to exogenous sources of nitrous oxide and/or associated with elevated FeNO
  • Unable to perform FeNO measurement
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748642


Locations
United States, Massachusetts
Northeast Medical Research Associates, Inc
North Dartmouth, Massachusetts, United States, 02747
United States, Tennessee
New Orleans Center for Clinical Research; Volunteer Research Group
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02748642     History of Changes
Other Study ID Numbers: GB30030
First Submitted: April 6, 2016
First Posted: April 22, 2016
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases