Phase 1, First-in-human, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, of ORKA-001 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
- Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]
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-001 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, and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study will enroll approximately 24 healthy volunteers. The ORKA-001 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
- •Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit/s defined in the protocol
- •Using a highly effective method of contraception from admission through the end of the study.
- •Willing to abstain from regular, continuous alcohol use or tobacco use as per protocol
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
- •History of severe allergic reactions or hypersensitivity
- •Actively nursing or lactating
- •Use of 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-001
Participants will receive subcutaneous injection of ORKA-001 at either 300 mg, 600 mg or 1200 mg.
干预措施: ORKA-001 (Drug)
Placebo
Participants will receive a subcutaneous injection of placebo comparator.
干预措施: Placebo (Other)
结局指标
主要结局
Number and frequency of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Day 1 through one year
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, and physical examinations.
次要结局
- Maximum observed serum concentration of ORKA-001(Day 1 through one year)
- Time to CMax (TMax) of ORKA-001(Day 1 through one year)
- Area Under the Serum Concentration-Time Curve (AUC) of ORKA-001(Day 1 through one year)
- Terminal elimination half-life (T1/2)(Day 1 through one year)