A First-In-Human, Randomized, Double-Blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ALTB-268 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Incidence of ALTB-268 Treatment-Emergent Adverse Events
研究概览
简要总结
This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.
详细描述
This is a Phase I, first-in-human, randomized, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ALTB-268 in healthy volunteers. Up to 40 and 24 healthy volunteers will be recruited in single and multiple ascending doses, respectively.
The primary objective is to assess the safety and tolerability of subcutaneously (sc) administered ALTB-268 in healthy volunteers. The secondary objective is to assess the plasma pharmacokinetics of sc administered ALTB-268 in healthy volunteers. The exploratory objectives are to assess the pharmacodynamics and evaluate immunogenicity of sc administered ALTB-268 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Written Informed Consent and willingness to comply with the study restrictions.
- •Sex: male or female volunteers.
- •Age: 18 to 55 years, inclusive, at screening.
- •Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening.
- •Weight: 50 kg to 110 kg, inclusive, at screening.
- •Healthy volunteers: Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis
排除标准
- •Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
- •Use of any investigational drug or device within 30 days or five half-lives whichever is longer, of the first dose of study drug.
- •Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the volunteers.
- •Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in emergency department.
研究组 & 干预措施
ALTB-268
Subcutaneous dose in healthy volunteers
干预措施: ALTB-268 (Biological)
Placebo
Subcutaneous dose in healthy volunteers
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of ALTB-268 Treatment-Emergent Adverse Events
时间窗: through study completion, up to day 120 of the study
Adverse events (AEs) - severity of the AEs will be graded using the most current version of the Common Terminology Criteria for AE (CTCAE) (V5.0) 5-point scale. The relationship between AEs and the study drug will be indicated as related or not related.
次要结局
- Pharmacokinetics of ALTB-268 Rac(through study completion, up to day 120 of the study)
- Pharmacokinetics of ALTB-268 Cmax(through study completion, up to day 120 of the study)
- Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.(through study completion, up to day 120 of the study)
- Pharmacokinetics of ALTB-268 t1/2(through study completion, up to day 120 of the study)
- Pharmacokinetics of ALTB-268 CL/F(through study completion, up to day 120 of the study)
- Pharmacokinetics of ALTB-268 tmax(through study completion, up to day 120 of the study)