NCT03463044已完成1 期
A Phase I, Randomised, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Ascending, Single, Intravenous Doses of MOTREM (LR12) in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Inotrem
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety and Tolerability: the Number of Subjects Experiencing Treatment Emergent Adverse Events
研究概览
简要总结
This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers
详细描述
This was a dose escalation study in healthy volunteers to evaluate the safety and pharmacokinetics of nangibotide in humans
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male
- •≥18 to ≤45 years old
- •Body mass index (BMI) between 18-30 kg/m² inclusive
- •Written informed consent to participate.
排除标准
- •Any clinically relevant acute or chronic diseases
- •Any history of drug or alcohol abuse
- •Any History of clinical significant disease as determined by medical history, physical examination or other evaluations.
研究组 & 干预措施
MOTREM 1
Experimental
nangibotide dose 1
干预措施: nangibotide (Drug)
Placebo
Placebo Comparator
Matched placebo
干预措施: Placebo (Drug)
MOTREM 2
Experimental
Nangibotide dose 2
干预措施: nangibotide (Drug)
MOTREM 3
Experimental
Nangibotide dose 3
干预措施: nangibotide (Drug)
MOTREM 4
Experimental
Nangibotide dose 4
干预措施: nangibotide (Drug)
MOTREM 5
Experimental
Nangibotide dose 5
干预措施: nangibotide (Drug)
MOTREM 6
Experimental
Nangibotide dose 6
干预措施: nangibotide (Drug)
MOTREM 7
Experimental
Nangibotide dose 7
干预措施: nangibotide (Drug)
MOTREM 8
Experimental
Nangibotide dose 8
干预措施: nangibotide (Drug)
结局指标
主要结局
Safety and Tolerability: the Number of Subjects Experiencing Treatment Emergent Adverse Events
时间窗: 30-44 days
The number of subjects experiencing treatment emergent adverse events was collected to assess the safety and tolerability of MOTREM (LR12) in comparison with placebo.
次要结局
- Statistical Analysis of LR12 PK Parameters: t1/2(t1/2 was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. t1/2 is determined over a period of time starting from 7 h and 45 min to 10h after start of the loading dose (decaying period).)
- Statistical Analysis of LR12 PK Parameters: AUC0-t(AUC0-t was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. AUC0-t is determined over a period of time starting time zero (predose) to the time of last observed concentration (t).)
- Pharmacokinetics (Maximum Plasma Concentration)(Maximum Plasma Concentration (Cmax) was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. Cmax is determined over a period of time starting from predose to 10h after start of the loading dose.)
- Statistical Analysis of LR12 PK Parameters: Tmax(tmax was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. tmax is determined over a period of time starting from predose to 10h after start of the loading dose.)
- Statistical Analysis of LR12 PK Parameters: Steady State Concentration During the Maintenance Infusion (Cavg30-465)(Cavg30-465 was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. Cavg30-465 is determined over a period of time starting from predose to 10h after start of the loading dose.)
- Statistical Analysis of LR12 PK Parameters: AUC0-∞(AUC0-∞ was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. AUC0-∞ is determined over a period of time starting time zero (predose) to infinity (cf. extrapolation formula in the above section).)
- Statistical Analysis of LR12 PK Parameters: CL(CL was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min (465 min). CL is calculated based on the perfusion rate (ng/kg/h) and the concentration at the end of perfusion (7h45min = 465min).)
- Statistical Analysis of LR12 PK Parameters: Volume of Distribution (V)(V was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. V is derived from both CL and ke which are calculated from the LR12 concentration time curve from predose to 10h after loading dose start.)
- Statistical Analysis of LR12 PK Parameters: t Last(t last was assessed only for Groups 3-8 who received loading dose over 15 min and maintenance dose over 7 h and 45 min. t last is determined as the time of last observed concentration which can go up to 10h after loading dose start.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy SubjectsHelicobacter Pylori InfectionNCT06190340TenNor Therapeutics (Suzhou) Limited40
已完成
1 期
Benzonatate Dose Tolerance StudyCoughNCT01690975Pfizer9
Unknown
1 期
TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral DensityOsteoporosisNCT05391776HJB (Hangzhou) Co., Ltd.32
已完成
1 期
A Phase I Study of ICP-022 in Healthy SubjectsSystemic Lupus ErythematosusRheumatoid ArthritisNCT03189017Innocare Pharma Australia Pty Ltd64
已完成
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy AdultsPrevention of Chikungunya Virus InfectionNCT03829384ModernaTX, Inc.39