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
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、医护人员、研究者)
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...
标识符
- NCT 编号
- NCT07847697
- 其他研究编号
- SCTB10-A201
日期
- 首次提交
- (13天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
相似试验
招募中
1 期
同适应症 · 同分期A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With DyslipidemiaHealthy ParticipantsDyslipidemiaHealthy ParticipantsNCT06980428AstraZeneca136
已完成
1 期
同适应症 · 同分期A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy ParticipantsHealthy ParticipantsNCT06568458Bristol-Myers Squibb71
已完成
1 期
同适应症 · 同分期Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy ParticipantsHealthy ParticipantsNCT03236844Hoffmann-La Roche114
已完成
1 期
同适应症 · 同分期Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730Healthy ParticipantsNCT03054194Eisai Inc.8
已完成
1 期
同适应症 · 同分期Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed StateHealthy ParticipantsNCT03133468EA Pharma Co., Ltd.200