Mild Atopic Asthma
Conditions
Brief summary
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.
Interventions
DRUGBITS7201A
BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
DRUGPlacebo
Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) | Baseline up to end of the study (Approximately 12 months) |
| Number of Participants with Anti-Therapeutic Antibodies (ATA) to BITS7201A and Associated Clinical Sequelae | Baseline up to end of the study (Approximately 12 months) |
Secondary
| Measure | Time frame |
|---|---|
| Apparent Volume of Distribution (Vz/F) of BITS7201A | 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 | 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) |
| Maximum Observed Serum Concentration (Cmax) of BITS7201A | 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 | 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 | Baseline up to end of the study (Approximately 12 months) |
| Half-Life (t1/2) of BITS7201A | 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 | 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) |
Countries
United States
Outcome results
None listed