Phase 1, First-in-human, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants.
详细描述
This is a single center, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) of ORKA-002 in healthy volunteers. The study will enroll approximately 24 healthy volunteers. The ORKA-002 dose will be administered by a subcutaneous injection.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants
- •18 to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2 at Screening
- •Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit(s)/s defined in the protocol
- •Using two methods of contraception (one being highly effective) from admission through the end of the study
排除标准
- •Any clinically significant medical condition or finding that, in the Investigator's opinion, is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
- •Known history of illicit drug use or drug abuse or harmful alcohol use
- •Known history of frequent tobacco or vaping use within 2 years prior to screening
- •Unwilling to abstain from regular, continuous alcohol use or tobacco use as per protocol
- •History of severe allergic reactions or hypersensitivity
- •Actively nursing, lactating, pregnant, or plans to be pregnant
- •Use of any investigational drug therapy within 30 days prior to enrollment
- •Unable to comply with study requirements or in the opinion of the Investigator should not participate in this study
研究组 & 干预措施
ORKA-002
Subcutaneous (SC) injection of ORKA-002
干预措施: ORKA-002 (Drug)
Placebo
Subcutaneous (SC) injection of placebo comparator
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events
时间窗: Day 1 through 1 year
Incidence of treatment-emergent adverse events and clinically significant changes from baseline in vital signs, electrocardiograms, and clinical laboratory parameters
次要结局
- Maximum observed serum concentration of ORKA-002(Day 1 through 1 year)
- Time to Cmax (Tmax) of ORKA-002(Day 1 through 1 year)
- Area under the serum concentration-time curve (AUC) of ORKA-002(Day 1 through 1 year)
- Terminal elimination half-life (T1/2)(Day 1 through 1 year)