A Phase Ia/Ib, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BLD-2660 in Healthy Volunteers and Patients With Lung Fibrosis or Liver Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
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)
盲法说明
Randomized, double-blind, placebo controlled
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent
- •Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
- •Have a negative urine drug screen/alcohol breath test on admission to clinic
- •Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 30 days following completion of dosing
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1
- •Normal BMI except liver fibrosis participants (BMI 18 to ≤35 kg/m2)
- •Be in general good health
- •Clinical laboratory values within normal range
- •Lung fibrosis participants-a diagnosis of lung fibrosis,
- •Liver fibrosis participants-a diagnosis of liver fibrosis; some abnormal laboratory values will be acceptable for the following; platelet count, albumin, serum creatinine and neutrophil-leukocyte ration
排除标准
- •Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol
- •History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
- •Blood donation or significant blood loss within 60 days prior to the first study drug administration
- •Plasma donation within 7 days prior to the first study drug administration
- •Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
- •Females who are pregnant or lactating
- •Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
- •Failure to satisfy the PI of fitness to participate for any other reason
- •Active infection or history of recurrent infections
- •Active malignancy and history of malignancy in the past 5 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
- •Chronic obstructive pulmonary disease
- •Antibiotic treatment within 3 months
- •Chronic medical condition
研究组 & 干预措施
cohort 1a - starting dose
Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers
干预措施: BLD-2660 (Drug)
cohort 1b- first SAD escalation
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)
干预措施: BLD-2660 (Drug)
cohort 1c-2nd SAD escalation
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (2nd dose escalation) in fasting state, followed by washout period and then single oral dose of BLD-2660 or placebo administered to healthy volunteers in fed state.
干预措施: BLD-2660 (Drug)
cohort 1d-3rd SAD escalation
Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)
干预措施: BLD-2660 (Drug)
cohort 1e-4th SAD escalation
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).
干预措施: BLD-2660 (Drug)
cohort 2a-1st MAD cohort
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers
干预措施: BLD-2660 (Drug)
cohort 2b-2nd MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
干预措施: BLD-2660 (Drug)
cohort 2c-3rd MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
干预措施: BLD-2660 (Drug)
cohort 2d-4th MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
干预措施: BLD-2660 (Drug)
cohort 2e-5th MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
干预措施: BLD-2660 (Drug)
cohort 2F-6th MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
干预措施: BLD-2660 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: 2 weeks
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Any observed changes in clinical safety laboratory results
时间窗: 2 weeks
Assessed by reviewing any observed changes in CBC, serum chemistry or urinalysis from baseline by dose. Results in subjects dosed with BLD-2660 treatment will be compared to those dosed with placebo.
Any observed changes in physical examinations
时间窗: 2 weeks
Assessed by reviewing any observed changes in physical examinations from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
Any observed changes in vital signs
时间窗: 2 weeks
Assessed by reviewing any observed changes in vital signs from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
Any observed changes in ECG
时间窗: 2 weeks
Assessed by reviewing any observed changes in ECG from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
次要结局
未报告次要终点