This is a randomized, placebo controlled and double blind study to evaluate the safety,
tolerability, pharmacokinetics, and clinical activity of FB704A in adult patients with severe
asthma. The study comprised a 4-week screening period, a 8-week treatment period and a
12-week follow-up period.
Approximately 40 subjects who meet the criteria for study entry are planned to be enrolled to
the study. Eligible subjects will be randomized to receive placebo or FB704A in a 1:1 ratio.
There are 20 subjects participate in each arm.
Eligibility will be checked in patients with severe asthma during the 4-week screening
period. Potential candidates should provide signed informed consent forms before starting the
screening activities. The subjects will receive four dose of 4 mg/kg FB704A or placebo. The
study drug will be administered as a 1-hour IV infusion.
Patients may administer albuterol as rescue medications as needed throughout the study.
Subjects will have site visits after receiving study drug for efficacy, safety, PK, and
biomarker evaluation (see Study Flow Chart). Subjects who prematurely withdraw from the study
will have an end of study (EOS) visit within 7 days.
Relative change in pre-bronchodilator FEV 1 , post-bronchodilator FEV 1, exhaled NO and
asthma symptom s will be evaluated during the study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.