Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    40
  • sponsor
    Oneness Biotech Co., Ltd.
Updated on 20 April 2022

Summary

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.

Description

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.

Details
Condition Severe Asthma
Treatment FB704A placebo, FB704A
Clinical Study IdentifierNCT05018299
SponsorOneness Biotech Co., Ltd.
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

18 to 70 years of age, either sex, any race
Diagnosed as severe asthma based on 2020GINA guideline
An ACT score is <20\
Induced sputum neutrophil count 50% of total sputum cells at Screening
Documented diagnosis of severe asthma (within past 5 years), and have at least one of the following: 12% and 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post bro nchodilator, and/or airway hyperresponsiveness (eg, positive methacholine challenge <8 mg/mL)
Nonsmoker or previous smoker with cumulative smoking history less than 10 pack years (pack year = 2 0 cigarettes smoked daily for 1 year). Previous smokers may no t have smoked within 1 year prior to Screening. A smoker is defined as a subject who has taken inhaled nicotine containing products (e.g. cigarette, cigar, pipe), including e cigarettes prior to screening
Must not have had an exacerbation of asthma for 4 weeks prior to Screening and must be on a stable medication regimen for asthma at least 4 weeks prior to Screening
Must be willing to give written informed consent to participate in the study
Must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction
Female subject of childbearing potential must have a negative serum pregnancy test at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical re cord of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment
Male subject must agree to use an adequate form of contraception for the duration of the
study and agree to have sexual relations only with women who use a highly effective birth
control method

Exclusion Criteria

Chronic Obstructive Pulmonary Disease (COPD)/other relevant lung disease (other than
4 weeks prior to/or Screening: upper/lower respiratory tract infection
asthma)
Screening: Inadequate amount or difficulty producing sputum
Screening: Sputum neut rophil count over 10 million/mL
Post bronchodilator FEV1 <1L
Screening: peripheral blood neutrophil (PBN) count <3000/µL
Allergy/sensitivity to study drug/excipients
Clinically significant chronic infectious disease(s) (eg, Human Immunodeficiency Virus
Breast feeding, pregnant/intends to become pregnant during study
[HIV], hepatitis B or C)
Requiring mechanical ventilation for respiratory eve nt within 6 months of Screening
Within 30 days of Screening: any other investigational drug
Medical condition(s) (eg, hema tologic, cardiovascular, renal, hepatic, neurologic, or
metabolic) or medication that may interfere with effect of study medication
Known history of active tuberculosis (TB) or evidence of tuberculosis infection as
Immunization with a live/attenuated vaccine within 4 weeks prior to treatment
defined by a positive purified protein derivative (PPD) skin test and/or interferon
gamma release assay. The interferon gamma release assay should be repeated in case of
an indeterminate result
Active infection, including opportunistic infections, requiring systemic therapy
Serum bilirubin > 2x upper limit of normal
within the past 2 weeks
Low platelet count (<100,000/mm3)
Dyslipidemia
A deep space infection within the past 2 years (including, but not limited to
Participation in any other clinical study
meningitis, epiglottitis, endocarditis, septic arthritis, fasciitis, abdominal or
Part of the staff personnel involved with the study
pleural abscess, or osteomyelitis)
Family member of investigational study staff
History of diverticulitis, diverticulosis requiring antibiotic treatment, or other
symptomatic lower gastrointestinal (GI) conditions that might predispose to
perforations
Evidence of active malignant disease, malignancies diagnosed within the previous 5
years (including hematological malignancies and solid tumors, except basal and
squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has
been excised and cured)
Liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >
x upper limit of normal
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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