NCT07042594进行中（未招募）1 期
A Randomized, Single-blind, Placebo-Controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD1119 in Healthy Participants
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
研究概览
简要总结
This is a Randomized, Single-blind, Placebo-Controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD1119 in Healthy Participants.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Male or female healthy participants (non-childbearing potential only), aged 18 to 65 years at screening, inclusive.
- •Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- •APTT, Prothrombin time (PT), INR, thrombin time (TT) within normal reference range (as per the local laboratory).
- •Haematology results within normal range, unless deemed not clinically significant by the Principal Investigator or delegate. Platelet count however must be within normal range per the local laboratory reference ranges.
- •Healthy as determined by no clinically significant findings by the Principal Investigator or delegate in medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG).
排除标准
- •Any uncontrolled or serious disease that may interfere with participation in the clinical trial and/or put the participant at significant risk (according to Principal Investigator or delegate's judgment) if he/she participates in the clinical trial.
- •History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease).
- •Systolic blood pressure (SBP) is less than 90 or greater than 140 mmHg and/or diastolic blood pressure (DBP) is less than 50 or greater than 95 mmHg after 10 minutes of supine rest, unless determined by the Principal Investigator or delegate to be not clinically significant.
- •Diagnosis of diabetes mellitus, history of gestational diabetes that has not been fully resolved is not permitted.
- •History or presence of:
- •Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history, such as Hemophilia A, Hemophilia B, Wiskott-Aldrich syndrome, von Willebrand disease (vWD);
- •Clinically significant anemia, in the opinion of the Principal Investigator or delegate;
- •Thromboembolic diseases;
- •Bleeding in the gastrointestinal tract or central nervous system;
- •Anticipated need for oral surgery or tooth extractions during the trial period;
- •Bleeding in the genitourinary tract;
- •Gum disease or active gum bleeding;
- •Planned surgery during the trial period.
研究组 & 干预措施
RBD1119 SAD experimental group
Experimental
Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD1119 on Day 1.
干预措施: RBD1119 (Drug)
Placebo SAD group
Placebo Comparator
Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
时间窗: Up to Day 85
次要结局
- Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0(After day 85)
- To characterize the pharmacokinetics (PK) as maximum plasma concentration (Cmax) of RBD1119 in healthy participants(Up to 48 hours post-dose)
- To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related antigen levels in healthy participants.(Up to Day 169.)
- To characterize the pharmacokinetics (PK) as Time to reach Cmax (Tmax) of RBD1119 in healthy participants(Up to 48 hours post-dose)
- To characterize the pharmacokinetics (PK) as area under the plasma concentration-time curve from the time zero to the last measurable concentration (AUC0-t) of RBD1119 in healthy participants(Up to 48 hours post-dose)
- To characterize the pharmacokinetics (PK) as area under the plasma concentration-time from time zero to infinity (AUC0-inf) of RBD1119 in healthy participants(Up to 48 hours post-dose)
- To characterize the pharmacokinetics (PK) as apparent terminal elimination half-life (t1/2) of RBD1119 in healthy participants(Up to 48 hours post-dose)
- To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related activity levels in healthy participants.(Up to Day 169.)
- To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in APTT in healthy participants.(Up to Day 169.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy SubjectsHealthy VolunteersNCT05653037Suzhou Ribo Life Science Co. Ltd.32
已完成
1 期
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy ParticipantsNon-alcoholic SteatohepatitisNCT05848440AstraZeneca48
已完成
1 期
To Assess the Safety and Tolerability of MTx-COVAB36 as a Therapeutic and Prophylactic Treatment Against COVID-19.SARS-CoV-2 InfectionNCT05351437Memo Therapeutics AG32
终止
1 期
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmakodynamics of AZD2820 After Multiple Ascending DosesObesityNCT01469923AstraZeneca18
招募中
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis (ALS) With Superoxide Dismutase Type 1 (SOD1) Gene MutationAmyotrophic Lateral SclerosisNCT06556394Ractigen Therapeutics.32