NCT01972893已完成1 期
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, a Selective Glucagon-like Peptide (GLP) 1 Agonist, Following Subcutaneous Administration in Healthy Volunteers.
适应症
干预措施
相关药物
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
- To evaluate Safety and tolerability of ZYD1
研究概览
简要总结
ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic cleavage, especially against dipeptidyl peptidase-4 (DPP-IV).
ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYD1 in normal healthy adult volunteers.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-45 years
- •Mentally, physically, and legally eligible to give informed consent
- •Male and female volunteers weighing between 50-75 kg and 45-75 kg respectively
- •Ability to communicate effectively with the study personnel
- •Willingness to adhere to the protocol requirements
- •For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.
排除标准
- •Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYD1 formulation
- •Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
- •Presence or history of severe gastrointestinal disease in the last 6 months
- •Presence or history of renal insufficiency at any time (serum creatinine above the upper limit of the reference range)
- •Active liver disease and/or liver transaminases greater than 1.5 X UNL
- •Subject with personal or family history of medullary thyroid cancer
- •Subject with personal or family history of multiple endocrine neoplasia syndrome type 2
- •Subject with serum calcitonin >50 ng/L
- •History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)
- •Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT) tests on the day of check in
- •History or presence of any medication in the last 14 days including any medication known to interact with the Cytochrome P (CYP) 450 system
- •History or presence of significant alcoholism or drug abuse within the past 1 year
- •History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
- •Difficulty with donating blood
- •Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg
- •Pulse rate less than 60/minute and more than 100/minute
- •Any clinically significant abnormal X-ray or laboratory findings during screening
- •History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
- •Major illness and/or major surgery in last 3 months
- •Volunteers who have participated in any drug research study other than the present trial within past 3 months
- •Volunteers who have donated one unit (350 ml) of blood in the past 3 months
- •For gender effect study, female volunteers with following criteria will not be recruited:
- •History of pregnancy or lactation in the past 3 months
- •Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility device or history of less than 1 year of menopause
- •Using hormonal contraceptives
- •Using hormone replacement therapy
- •Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
- •Positive urine pregnancy test on the day of check-in
研究组 & 干预措施
ZYD1
Experimental
Tablet ZYD1 5 to 50 mg subcutaneously Once a day (OD) or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)
干预措施: ZYD1 (Drug)
Placebo
Placebo Comparator
Tablet Placebo 5 to 50 mg subcutaneously OD or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate Safety and tolerability of ZYD1
时间窗: 21 days
The safety and tolerability shall be evaluated using physical examinations, standard laboratory tests (hematology, biochemistry and urine examination), and electrocardiogram (ECG). Spontaneously reported and solicited adverse events will also be used for safety parameters.
次要结局
- Pharmacokinetics (PK) and Pharmacodynamic (PD) effect after single and multiple subcutaneous dose administrations in healthy adult male volunteers Gender effect study.(1. For Plan I and III - Pre-dose (before dosing), 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, 24, 48, 72 and 120 hrs post dose 2. Plan II - Day 01 - Pre-dose, 1, 2, 3, 4 and 8 hours following first dosing. Day 02 to 06 - Pre-dose of each . Day 07 - Pre-dose, 1, 2, 3,)
研究者
研究点 (1)
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