Actively Recruiting
A Randomized, Placebo Controlled, Double Blind Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Multiple Intravenous Doses of FB704A in Adults With Severe Asthma
Led by Oneness Biotech Co., Ltd. · Updated on 2025-12-09
20
Participants Needed
9
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and clinical activity of FB704A in adults with severe asthma. This randomized, placebo-controlled, and double-blind Phase IIa study aims to better understand how FB704A works in patients who meet strict criteria for severe asthma, following guidelines from 2020. The study involves about 20 participants, divided evenly between receiving FB704A or a placebo. Eligible subjects will be randomly assigned to receive either FB704A or placebo through four intravenous infusions of 4 mg/kg over one hour each during the 8-week treatment period. The study includes a 4-week screening period to confirm eligibility and a 12-week follow-up period after treatment. Patients can continue to use rescue medications like short-acting beta agonists as needed throughout the study. Participants will visit the study site for evaluations of efficacy, safety, pharmacokinetics, and biomarkers during and after treatment. Researchers will measure changes in lung function (FEV1 before and after bronchodilator), exhaled nitric oxide, asthma symptoms, and asthma control test scores. Safety is monitored by recording adverse events throughout the treatment and follow-up periods. Total participation lasts approximately 24 weeks, including screening, treatment, and follow-up.
CONDITIONS
Brief Title
Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any sex, any race
- Diagnosed with severe asthma based on 2020 GINA guideline
- Asthma Control Test (ACT) score below 20
- Induced sputum neutrophil count of 50% or more during screening
- Documented severe asthma diagnosis within past 5 years
- Must meet at least one lung function or airway responsiveness criteria: at least 12% and 200 mL improvement in FEV1 post-bronchodilator, or airway hyperresponsiveness, or airway variability within past 24 months, or average daily peak expiratory flow variability over 10% in 2 weeks
- Nonsmoker or previous smoker with less than 10 pack-years and no smoking within 1 year prior to screening
- No severe asthma exacerbation for 4 weeks before screening and stable medication for at least 4 weeks
- Able and willing to provide written informed consent
- Able to comply with dosing, visit schedule, and sputum induction
- Female of childbearing potential must have negative pregnancy test and use effective contraception during study
- Female not of childbearing potential must have surgical sterilization or be at least 1 year postmenopausal
- Male must agree to use contraception and have sexual relations only with women using effective birth control
You will not qualify if you...
- Chronic obstructive pulmonary disease (COPD) or other lung diseases besides asthma
- Respiratory tract infection within 4 weeks before screening
- Inadequate sputum sample or difficulty producing sputum
- Sputum neutrophil count over 10 million/mL at screening
- Peripheral blood neutrophil count below 2000/µL
- Chronic infectious diseases such as HIV or hepatitis B/C
- Allergy or sensitivity to study drug or its ingredients
- Pregnant, breastfeeding, or planning pregnancy during study
- Mechanical ventilation for respiratory event within 6 months before screening
- Medical conditions or medications that could interfere with study drug
- Use of any other investigational drug within 30 days before screening
- Active or history of tuberculosis infection
- Active infections needing systemic therapy within 2 weeks before screening
- Serious infections in past 2 years like meningitis or abscess
- History of gastrointestinal conditions that could increase risk of perforations
- Vaccination with live or attenuated vaccine within 4 weeks before treatment
- Active cancer or history of cancer in last 5 years except certain skin or cervical cancers
- Elevated liver enzymes or bilirubin beyond specified limits
- Low platelet count below 100,000/mm3
- Dyslipidemia
- Participation in other clinical studies
- Study staff or family member of study personnel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Approximately 8 weeks
Participants receive four intravenous doses of FB704A or placebo as part of the treatment.
Multiple visits for dosing and evaluation after each dose
Duration - Up to 12 weeks after the last dose
Participants are monitored for efficacy, safety, pharmacokinetics, and biomarker evaluation after treatment completion.
Scheduled visits on Day 36, 57, 85, 113, and 141 for assessments
Trial Site Locations
Total: 9 locations
1
NTUH Hsin-Chu Branch
Hsinchu, Taiwan
Withdrawn
2
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
3
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
4
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
5
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
6
Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
7
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Taipei, Taiwan
Actively Recruiting
8
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Actively Recruiting
9
Taipei Veterans General Hospital
Taipei, Taiwan
Withdrawn
Research Team
J
Jessica Ho, Director
S
Sophie Weng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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