Brigham Research Institute (BRI) - Brigham and Women's Hospital

Condition

• Asthma

Eligibility

Eligible Ages

Between 18 Years and 70 Years

Eligible Sex

All

Accepts Healthy Volunteers

Yes

Criteria

Inclusion Part A and B

- Participants must be capable of giving informed consent and have provided informed
consent.

- Participants must be 18 to 65, inclusive at time of signing of informed consent.

- Participants must have a Body Mass Index between 18.0 to 30 kg/m^2 and total body
weight ≥ 40 kg at screening.

- Participants must be overtly healthy as determined by the investigator based on
medical evaluation and study screening procedures.

- Female participants must be of non-childbearing potential.

Inclusion Part C

- Participants must be capable of giving informed consent and have provided informed
consent.

- Participants must be 18 to 70, inclusive at time of signing of informed consent.

- Body mass index between 18.0 to 35 kg/m^2 and total body weight ≥ 40 kg at
screening.

- Participants must have documentation of physician diagnosed asthma for ≥ 12 months
prior to screening.

- Participants must have documented bronchodilator responsiveness of forced expiratory
volume in 1 second (FEV1) ≥ 10% in the 10 years before screening or at the screening
visit.

- Participants must have a pre-bronchodilator percent predicted FEV1 ≥ 50% at
screening visit and Day -1. For participants on high-dose ICS, participants must
have a percent-predicted FEV1 ≥ 70% at screening visit and on day -1.

- Participants must have peripheral blood eosinophils ≥ 200 cells/μl at screening
visit and Day -1.

- Participants must have a fractional exhaled nitric oxide (FeNO) ≥ 25 ppb at
screening visit and Day -1.

- Participant must not use inhaled corticosteroids (ICS) or must be treated with
low-dose, medium-dose, or high-dose ICS and on a stable dose for a minimum of 12
weeks prior to screening.

Exclusion (applicable to all study parts)

- History of malignancy (except for in situ cervical cancer or surgically excised
non-melanoma skin cancer occurring more than 5 years prior to randomization).

- History of anaphylaxis or hypersensitivity to biologic therapy or sensitivity to
mammalian derived products.

- History of immunodeficiency or history of severe infection within the last 3 years
requiring IV antibiotics.

- History of tuberculosis (TB), TB symptoms, or positive interferon gamma release
assay.

- History of untreated or unresolved helminthic infection within 24 weeks of day 1.

- Positive human immunodeficiency virus (HIV) antibodies, hepatitis B core antigen,
hepatitis B core antibody, or hepatitis C virus (HCV) ribonucleic acid (RNA).

- Male participants unwilling to follow contraceptive requirements.

Additional Exclusion for Part C only

- Female of childbearing potential not willing to use 2 methods of contraception with
one being a highly effective method of contraception.

- History of pulmonary disease that may interfere with interpretation of study
results.

- History of upper respiratory infection within 6 weeks of screening.

- Asthma Control Questionnaire (ACQ-6) > 3.

- Asthma symptoms or exacerbations requiring 2 or more systemic corticosteroid bursts
(≥10 mg/day prednisone or equivalent for ≥ 3 days each) in the previous 12 months.

- More than one hospitalization or emergency department visit in the last year.

- History of life-threatening asthma exacerbation after the 12 years age requiring
admission to intensive care unit.

Recruiting Locations

Study Contact