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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Cohort A: BITS7201A Dose Level 1 Subcutaneous (SC) | Experimental | Healthy participants will receive a single SC dose of BITS7201A dose Level 1 on Day 1. |
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| Part A Cohort B: BITS7201A Dose Level 2 SC | Experimental | Healthy participants will receive a single SC dose of BITS7201A dose Level 2 on Day 1. |
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| Part A Cohort C: BITS7201A Dose Level 4 SC | Experimental | Healthy participants will receive a single SC dose of BITS7201A dose Level 4 on Day 1. |
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| Part A Cohort D: BITS7201A Dose Level 4 Intravenous (IV) | Experimental | Healthy participants will receive a single IV dose of BITS7201A dose Level 4 on Day 1. |
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| Part A Cohort E: BITS7201A Dose Level 6 IV | Experimental | Healthy participants will receive a single IV dose of BITS7201A dose Level 6 on Day 1. |
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| Part A: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BITS7201A | Drug | BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B. |
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| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Total Clearance (CL/F) of BITS7201A |
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Inclusion Criteria:
General Inclusion Criteria:
Additional Inclusion Criteria for Participants With Mild Atopic Asthma:
Exclusion Criteria:
General Exclusion Criteria:
Additional Exclusion Criteria for Participants With Mild Atopic Asthma:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Orleans Center for Clinical Research; Volunteer Research Group | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30616547 | Derived | Staton TL, Peng K, Owen R, Choy DF, Cabanski CR, Fong A, Brunstein F, Alatsis KR, Chen H. A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers. BMC Pulm Med. 2019 Jan 7;19(1):5. doi: 10.1186/s12890-018-0763-9. |
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| Placebo Comparator |
Healthy participants will receive a single SC or IV dose of placebo matched to BITS7201A on Day 1. |
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| Part B Cohort F: BITS7201A Dose Level 3 SC | Experimental | Healthy participants will receive a single SC dose of BITS7201A dose Level 3 every 4 weeks (Q4W) on Days 1, 29, and 57. |
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| Part B Cohort G: BITS7201A Dose Level 4 SC | Experimental | Healthy participants will receive a single SC dose of BITS7201A dose Level 4 Q4W on Days 1, 29, and 57. |
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| Part B Cohort H: BITS7201A Dose Level 5 SC | Experimental | Healthy participants will receive SC dose of BITS7201A dose Level 5 Q4W on Days 1, 29, and 57. |
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| Part B Cohort I:BITS7201A Dose Level 5 SC (Mild Atopic Asthma) | Experimental | Mild atopic asthma participants will receive SC dose of BITS7201 dose Level 5 Q4W on Days 1, 29, and 57. |
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| Part B: Placebo | Placebo Comparator | Healthy participants or mild atopic asthma participants will receive SC doses of placebo matched to BITS7201A Q4W on Days 1, 29, and 57. |
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| Placebo | Drug | Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B. |
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| 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 | 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) |
| 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) |
| 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) |