NCT04559971已完成早期 1 期
A Randomised, Double-blind, Placebo-controlled Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SLN124 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.
详细描述
This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN124 after single ascending s.c. doses in healthy male and female subjects.
Up to 3 cohorts of 24 healthy volunteers will be enrolled. Each subject will receive a single dose of SLN124 or placebo given by subcutaneous (s.c) injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normotensive male or female volunteers, with a body mass index of 18.0-30.0 kg/m
- •Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine.
- •Agree to follow the contraception requirements of the trial.
- •Able to give fully informed written consent.
- •Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
排除标准
- •History or presence of iron deficiency or iron deficiency anaemia and/or currently receiving oral or parenteral iron supplementation as treatment for those conditions.
- •Positive tests for hepatitis B & C, HIV
- •Drug or alcohol abuse.
- •Smoke more than 10 cigarettes (or equivalent) daily.
- •Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication (with the exception of hormone replacement therapy [HRT]) during the 28 days before first dose of trial medication.
- •Use of supplement(s) during the 28 days before screening.
- •Participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months.
- •Clinically relevant abnormal medical history or concurrent medical condition.
- •Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.
研究组 & 干预措施
1.0mg/kg
Experimental
Drug: SLN124
干预措施: SLN124 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
3.0mg/kg
Experimental
Drug: SLN124
干预措施: SLN124 (Drug)
Optional Cohort
Experimental
An additional dose level may be explored
干预措施: SLN124 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 8 weeks
safety and tolerability
次要结局
- Pharmacokinetic: peak plasma concentration (Cmax)(7 days)
- Pharmacokinetic: area under the plasma concentration (AUC)(7 days)
- Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)(7 days)
研究者
研究点 (1)
Loading locations...
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