NCT07205432招募中1 期
A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects
Shanghai Xitaili Biomedicine Technology co., Ltd.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6月13日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects.
SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Inclusion Criteria for Subjects in SAD part:
- •Age ≥ 18 and < 65 years at screening.
- •Body mass index (BMI) ≥ 18.5 kg/m² and < 28.0 kg/m² at screening.
- •Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- •Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
- •Inclusion Criteria for Subjects in MAD part:
- •Age ≥ 18 and < 65 years at screening.
- •BMI ≥ 18.5 kg/m2 且 < 40.0kg/m².
- •Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- •Stable body weight (fluctuation < 5%) for at least 3 months prior to screening.
- •Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
排除标准
- •Exclusion Criteria for Subjects in SAD part:
- •History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
- •Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
- •History of acute or chronic pancreatitis.
- •Symptomatic gallbladder disease.
- •Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
- •Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
- •Female subjects with positive pregnancy test or lactation.
- •Exclusion Criteria for Subjects in MAD part:
- •History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
- •UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
- •Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or gastrointestinal surgeries that may compromise safety or data interpretation.
- •History of acute or chronic pancreatitis.
- •Symptomatic gallbladder disease.
- •Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
- •Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
- •Female subjects with positive pregnancy test or lactation.
研究组 & 干预措施
XTL6001
Experimental
Interventional: The SAD study involves single administration of XLT6001, while the MAD study involves administration of XLT6001 for no more than 4 weeks.
干预措施: XTL6001 (Drug)
Placebo
Placebo Comparator
Placebo: The SAD study involves single administration of Placebo, while the MAD study involves administration of Placebo for no more than 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
时间窗: SAD: up to Day 8 MAD: up to Day 57
次要结局
- Tmax of XTL6001(Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.)
- The maximum plasma concentration (Cmax) of XTL6001(Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.)
- Body weight(MAD: up to Day57)
- Body mass index （BMI）(MAD: up to Day57)
- Elimination half-life (T1/2) of XTL6001(Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.)
- Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001(Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.)
- AUC0-t of XTL6001(Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.)
- Uric acid(MAD: up to Day57)
- Waist circumference(MAD: up to Day57)
- Waist-to-hip ratio(MAD: up to Day57)
- Blood lipids(MAD: up to Day57)
- Blood glucose(MAD: up to Day57)
- Insulin(MAD: up to Day57)
- Anti-drug antibodies (ADA)(MAD: up to Day57)
- ADA(MAD: up to D57)
研究者
研究点 (1)
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