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Mild Atopic AsthmaPhase 1NCT02748642

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

A Phase 1 study testing BITS7201A in people with Mild Atopic Asthma, run by Genentech, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Mild Atopic Asthma
What is being tested?
BITS7201A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
1 siteUnited States
Study dates
7 Apr 2016to 14 Jun 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New Orleans Center for Clinical Research; Volunteer Research Group

    Knoxville, Tennessee, 37920

Other trials in United States

About this study

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

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.

Being tested
BITS7201A, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BITS7201ADrug

    Also called RO7040547

    BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.

  • PlaceboDrug

    Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.

Study groups in NCT02748642
Study groupRoleWhat they receive
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.
Receives: Drug: BITS7201A
Part A Cohort B: BITS7201A Dose Level 2 SCExperimentalHealthy participants will receive a single SC dose of BITS7201A dose Level 2 on Day 1.
Receives: Drug: BITS7201A
Part A Cohort C: BITS7201A Dose Level 4 SCExperimentalHealthy participants will receive a single SC dose of BITS7201A dose Level 4 on Day 1.
Receives: Drug: BITS7201A
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.
Receives: Drug: BITS7201A
Part A Cohort E: BITS7201A Dose Level 6 IVExperimentalHealthy participants will receive a single IV dose of BITS7201A dose Level 6 on Day 1.
Receives: Drug: BITS7201A
Part A: PlaceboPlacebo comparatorHealthy participants will receive a single SC or IV dose of placebo matched to BITS7201A on Day 1.
Receives: Drug: Placebo
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.
Receives: Drug: BITS7201A
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.
Receives: Drug: BITS7201A
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.
Receives: Drug: BITS7201A
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.
Receives: Drug: BITS7201A
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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline up to end of the study (Approximately 12 months)

  2. Number of Participants with Anti-Therapeutic Antibodies (ATA) to BITS7201A and Associated Clinical Sequelae

    Measured: Baseline up to end of the study (Approximately 12 months)

Secondary outcomes (7)

  1. Maximum Observed Serum Concentration (Cmax) of BITS7201A

    Measured: 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)

  2. Total Clearance (CL/F) of BITS7201A

    Measured: 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)

  3. Apparent Volume of Distribution (Vz/F) of BITS7201A

    Measured: 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)

  4. Area under the Concentration-Time Curve (AUC) of BITS7201A

    Measured: 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)

  5. Half-Life (t1/2) of BITS7201A

    Measured: 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)

  6. Bioavailability (Percentage of Administered Dose Reaching the Systemic Circulation) of BITS7201A

    Measured: 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)

  7. Number of Participants with Impact of ATA Status

    Measured: Baseline up to end of the study (Approximately 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study start7 Apr 2016
  3. Primary completion14 Jun 2017
  4. Study completion14 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Investigator
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748642
Sponsor's protocol ID
GB30030
Status last verified
Jul 2018
First submitted
6 Apr 2016
Last updated
3 Jul 2018
Results posted
No

Publications

  • 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.

    PubMed 30616547

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BITS7201A in people with Mild Atopic Asthma, run by Genentech, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (AEs) (time frame: Baseline up to end of the study (Approximately 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02748642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.

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