A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending-Dose Study to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of UPB-101 in Subjects With Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Number of Treatment-emergent Adverse Events and Serious Adverse Events
研究概览
简要总结
The goals of this clinical study were to assess the safety, tolerability, blood levels, and disease impact of UPB-101 when given to adults with mild asthma. Eligible participant were consecutively assigned to 1 of 3 to 5 planned treatment groups. Each treatment group consisted of 8 individuals, six of whom will received active drug (UPB-101) and 2 who received placebo. Neither the study doctors nor the participants knew which participants were assigned to active study drug and which were assigned to placebo. The study was performed at 4 experienced research sites in the United Kingdom.
详细描述
This was a two-part phase 1b, multi-center randomized, double-blind (Investigator and Subject blinded; Sponsor unblinded), placebo-controlled, multiple ascending-dose study to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of UPB-101 administered subcutaneously (SC) to adult subjects with asthma.
The study consists of Part A and Part B. Part A included 3 cohorts with pre-set dosing regimens. Part B (optional) included up to 2 additional cohorts whose doses and dosing intervals decided based upon the safety, PK, and PD results from Part A (i.e., an adaptive design), as applicable. The regimens selected for Part B did not exceed the exposures (i.e., doses and/or dosing intervals) included in Part A. Eight subjects were randomized per cohort (6 active, 2 placebo). Thus, a total of 32 subjects were enrolled in the study with 24 subjects in Part A and 8 in Part B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 60, and has physician-diagnosed asthma
- •Body mass index (BMI) between 18 and 35 kg/m2
- •Blood eosinophil cell count ≥200 (OR ≥150 combined with fractional exhaled nitric oxide [a measure of lung airway inflammation] >25) at one screening visit and ≥150 at the other screening
- •Agrees to follow the required contraceptive techniques
- •Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug
- •Able to perform spirometry (breathing tests)
- •Asthma and non-biologic asthma medication have been stable for the past 2 months
排除标准
- •Employee, consultant, and/or immediate family member of any person involved in the conduct of the study
- •Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients
- •Pregnant or breastfeeding female
- •Unable to fast and avoid strenuous exercise for 9 hours prior to each site visit
- •Serious allergic reaction to any injected drug
- •Significantly abnormal clinical laboratory test results or a significant medical condition
- •Recently donated blood (including blood products) or experienced significant loss of blood
- •Has pacemaker or a significantly abnormal electrocardiogram
- •An active or a serious infection in the past 8 weeks
- •Poorly-controlled diabetes or abnormal kidney function
- •Tests positive to illicit drugs or nicotine and cannot limit alcohol consumption
- •Tests positive for human immunodeficiency virus antibodies (HIV), hepatitis B, hepatitis C antibodies, or tuberculosis
- •Received any vaccine within the past month
- •Received any immunosuppressant therapies in the past
- •Received an antibody or therapeutic biologic product in the last 6 months
- •Received steroids (other than inhaled) in the past 2 months
- •Participated recently in a clinical study
- •Current tobacco smokers or has smoked within the last year
- •Tested positive for COVID-19 in the past month
研究组 & 干预措施
Active substance 1
UPB-101 Cohort 1
干预措施: Placebo (Drug)
Active substance 2
UPB-101 Cohort 2
干预措施: UPB-101 (Drug)
Active substance 1
UPB-101 Cohort 1
干预措施: UPB-101 (Drug)
Active substance 2
UPB-101 Cohort 2
干预措施: Placebo (Drug)
Active substance 3
UPB-101 Cohort 3
干预措施: UPB-101 (Drug)
Active substance 3
UPB-101 Cohort 3
干预措施: Placebo (Drug)
Active Substance 4
UPB-101 Cohort 4
干预措施: UPB-101 (Drug)
Active Substance 4
UPB-101 Cohort 4
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment-emergent Adverse Events and Serious Adverse Events
时间窗: Baseline through 24 weeks
Overall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)
次要结局
- Incidence of Anti-drug Antibodies(Baseline through Week 32)
- Maximum Observed Concentration of UPB-101(First Dose = Day 1. Last Dose = Baseline through 32 weeks.)
- Time to Maximum Observed Concentration of UPB-101(Baseline through 32 weeks)
- Area Under the Concentration-time Curve Under One Dosing Interval of UPB-101(Baseline through 32 weeks)