NCT07847697尚未招募1 期
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Single and Multiple Doses of SCTB10 in Healthy Participants and Patients With Hemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- dose limited toxicity (DLT).
研究概览
简要总结
Phase Ia to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of SCTB10 following a single dose in healthy participants
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent prior to initiation of any study procedures.
- •Healthy male participants aged 18 to 50 years (inclusive).
- •Body mass index (BMI) between 19 and 26 kg/m² (inclusive), and body weight ≥ 50 kg.
- •Agreement by the participant and their partner to use highly effective contraception during the study period and for 6 months following the last dose of study medication.
排除标准
- •History of hypersensitivity or allergy to monoclonal antibodies, or a known atopic constitution.
- •History of coronary and/or peripheral atherosclerosis, or congestive heart failure.
- •Presence of high-risk factors for thrombosis.
- •Clinically significant abnormal findings during screening, as determined by the investigator.
- •Abnormal infectious disease screening results.
- •Abnormal results in urine drug screening or breath alcohol test.
- •Use of any medication or dietary supplements within 14 days prior to the first dose.
- •Participation in another clinical trial involving the use of any investigational drug or medical device within 12 weeks prior to screening.
- •Receipt of any biologic products (including antibodies or their derivatives) within 16 weeks prior to dosing (or within 5 half-lives, whichever is longer).
研究组 & 干预措施
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
SCTB10 group
Experimental
干预措施: SCTB10 (Drug)
结局指标
主要结局
dose limited toxicity (DLT).
时间窗: Up to approximately 6 weeks.
To determine the maximum tolerated dose (MTD) and/or RP2D.
Incidence of TEAE.
时间窗: Up to approximately 25 weeks.
TEAE refers to 'treatment emergent adverse event'.
Incidence of TRAE.
时间窗: Up to approximately 25 weeks.
Incidence of TEAE related to the experimental drug.
Incidence of SAE.
时间窗: Up to approximately 25 weeks
SAE refers to 'serious adverse event'.
次要结局
- Blood Concentrations of SCTB10(Up to approximately 25 weeks)
- Activated Partial Thromboplastin Time and Thrombin Generation Assay(Up to approximately 25 weeks)
- Incidence of anti-SCTB10 antibody (ADA) and neutralizing antibody (Nab).(Up to approximately 25 weeks)
研究者
研究点 (1)
Loading locations...
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