NCT07065032已完成1 期
A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Phase Id/IIa Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ZT002 Injection in Adult Chinese Subjects With Type 2 Diabetes Mellitus (T2DM)
Beijing QL Biopharmaceutical Co.,Ltd1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年2月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction.
研究概览
简要总结
This study will comprise a randomized, double blind, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in subjects with type 2 diabetes mellitus (T2DM).
详细描述
This study is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending-dose Phase Id/IIa clinical study in Chinese T2DM subjects after diet and exercise intervention and/or treatment with oral hypoglycemic agent to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of ZT002 injection in adult subjects with type 2 diabetes mellitus. Participants in each cohort will be randomized to receive a multiple SC doses of either ZT002 or matching placebo every 2 weeks.
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
- 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
- 否
入选标准
- •Males and females aged 18 to 65 years (inclusive, based on age at the time of signing the informed consent form);
- •Body mass index (BMI) at screening ranges from 22-35 kg/m² (inclusive); BMI = Weight(kg)/ Height (m²).
- •Type 2 diabetes mellitus has been diagnosed for ≥12 weeks according to the diagnostic and classification criteria for diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the WHO Recommendations for Diagnosis Using Glycosylated Hemoglobin (HbA1c) (2011) supplemental diagnostic criteria; and one of the following conditions is met:
- •Controlled by diet and exercise for 12 weeks prior to screening, with no prior use of any hypoglycemic drugs
- •Use of only one oral hypoglycemic agent (including metformin, α-glucosidase inhibitors, dipeptidyl peptidase-4 [DPP-4] inhibitors, and sodium-glucose cotransporter 2 [SGLT2] inhibitors) in the 12 weeks prior to screening, but no further use in the 14 days prior to screening;
- •At screening and before randomization: 7.0% ≤ glycosylated hemoglobin (HbA1c) ≤ 10.5% (hospital laboratory);
- •At screening and before randomization: fasting venous blood glucose ≤ 13.9 mmol/L (hospital laboratory);
- •Exclusion criteria (Subjects meeting any of the following criteria will not be enrolled in the trial):
- •History of specific allergies (asthma, eczema, etc.) or allergic constitution, or history of allergy to two or more drugs and foods, especially to the investigational drug and its excipients or GLP-1-containing drugs;
- •Confirmed or suspected diagnosis of type 1 diabetes mellitus or specific types of diabetes mellitus (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug or chemically induced diabetes mellitus, etc.) for other causes prior to screening;
- •History of acute and chronic pancreatitis, history of symptomatic gallbladder disease (except for cholecystectomy), history of pancreatic injury, and other high risk factors for pancreatitis prior to screening;
- •Previous personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2); or hyperthyroidism or hypothyroidism on stable dose medication for less than 3 months;
- •Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic syndrome (HHS), diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma within 12 months prior to screening;
- •Proliferative retinopathy, maculopathy, symptomatic diabetic neuropathy, intermittent claudication, and diabetic foot that are unstable or require treatment within 12 months prior to screening;
- •Severe hypoglycemic (grade 3 hypoglycemic) events within 6 months prior to screening, or 3 or more hypoglycemic events (blood glucose < 3.9 mmol/L) within 1 month prior to randomization, or recurrent hypoglycemia-related symptoms (1 or more per week) prior to randomization;
排除标准
- 未提供
研究组 & 干预措施
ZT002 Injection dose 1
Experimental
Dose 1 administered subcutaneously, Q2W
干预措施: ZT002 Injection (Drug)
ZT002 Injection dose 2
Experimental
Dose 2 administered subcutaneously, Q2W
干预措施: ZT002 Injection (Drug)
ZT002 Placebo
Placebo Comparator
Placebo administered subcutaneously, Q2W
干预措施: ZT002 Placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events and serious adverse events; Number of participants with injection site reaction.
时间窗: up to 155days
次要结局
- Area under the concentration-time curve at the end of dosing interval(τ) at steady state (AUC0-τ,SS)(up to 155days)
- Time to Cmax at steady state (Tmax,ss)(up to 155days)
- Steady-state peak concentration (Css_max), mean steady-state concentration (Css_av)(up to 155days)
- Change from baseline of venous fasting plasma glucose(up to 155days)
- Change from baseline of weight (kg).(up to 155days)
- Incidence of anti-drug antibody against ZT002(up to 155days)
研究者
研究点 (1)
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