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BITS7201A

Phase 1

Mild Atopic Asthma | Small molecule | Respiratory |Roche Holding AG|Last Updated: Jul 3, 2018

Success Probability

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

BITS7201A · 1 trial · 1 indication

Phase 1 1
NCT02748642A Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of BITS7201A in Healthy Volunteers and Participants With Mild Atopic AsthmaMild Atopic Asthma
COMPLETED67 Analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of BITS7201A in Healthy Volunteers and Participants With Mild Atopic Asthma
Mild Atopic Asthma
NCT0274864267
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A Cohort A: BITS7201A Dose Level 1 Subcutaneous (SC)EXPERIMENTALHealthy participants will receive a single SC dose of BITS7201A dose Level 1 on Day 1.
Part A Cohort B: BITS7201A Dose Level 2 SCEXPERIMENTALHealthy participants will receive a single SC dose of BITS7201A dose Level 2 on Day 1.
Part A Cohort C: BITS7201A Dose Level 4 SCEXPERIMENTALHealthy participants will receive a single SC dose of BITS7201A dose Level 4 on Day 1.
Part A Cohort D: BITS7201A Dose Level 4 Intravenous (IV)EXPERIMENTALHealthy participants will receive a single IV dose of BITS7201A dose Level 4 on Day 1.
Part A Cohort E: BITS7201A Dose Level 6 IVEXPERIMENTALHealthy participants will receive a single IV dose of BITS7201A dose Level 6 on Day 1.
Part A: PlaceboPLACEBO_COMPARATORHealthy participants will receive a single SC or IV dose of placebo matched to BITS7201A on Day 1.
Part B Cohort F: BITS7201A Dose Level 3 SCEXPERIMENTALHealthy participants will receive a single SC dose of BITS7201A dose Level 3 every 4 weeks (Q4W) on Days 1, 29, and 57.
Part B Cohort G: BITS7201A Dose Level 4 SCEXPERIMENTALHealthy participants will receive a single SC dose of BITS7201A dose Level 4 Q4W on Days 1, 29, and 57.
Part B Cohort H: BITS7201A Dose Level 5 SCEXPERIMENTALHealthy participants will receive SC dose of BITS7201A dose Level 5 Q4W on Days 1, 29, and 57.
Part B Cohort I:BITS7201A Dose Level 5 SC (Mild Atopic Asthma)EXPERIMENTALMild atopic asthma participants will receive SC dose of BITS7201 dose Level 5 Q4W on Days 1, 29, and 57.
Part B: PlaceboPLACEBO_COMPARATORHealthy participants or mild atopic asthma participants will receive SC doses of placebo matched to BITS7201A Q4W on Days 1, 29, and 57.

Interventions

NameTypeDescription
BITS7201ADRUGBITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
PlaceboDRUGPlacebo 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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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about BITS7201A

What is BITS7201A used for?

BITS7201A is an investigational small molecule being developed for the treatment of mild atopic asthma. It is currently in Phase 1 clinical development and has been studied in a completed trial involving participants with mild atopic asthma.

Who makes BITS7201A?

BITS7201A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 1 clinical development for mild atopic asthma.

What phase is BITS7201A in?

BITS7201A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is BITS7201A in?

BITS7201A has been studied in one completed Phase 1 trial, NCT02748642, which investigated its safety, pharmacokinetics, and immunogenicity in healthy volunteers and participants with mild atopic asthma. The trial enrolled 67 participants in the United States.

Is BITS7201A the same as any other drug?

No alternative names for BITS7201A have been disclosed. It is identified by its code name BITS7201A in clinical trial records.