NCT06974487尚未招募1 期
A Randomized, Double-Blind, Crossover Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD Profiles of a Single Dose of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects
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
- 30
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately.
Subjects undergo a screening phase of up to 3 weeks (D-21 to D-3). Eligible subjects are randomized in a 1:1:1:1:1:1 ratio into six dosing sequences, receiving single doses of GZR102 injection, GZR4 injection, and GZR18 injection across 3 cycles. A washout period of at least 1 week separates each cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- •Subjects (male or female) age 18-60 years old (inclusive) at the time of signing ICF.
- •Body weight ≥ 60 kg, body mass index (BMI) ≥ 24 kg/m2 and < 28 kg/m2 at screening.
- •No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.
排除标准
- •History of drug abuse prior to screening; or positive results for drug abuse at screening.
- •History of alcohol abuse defined as an average alcohol intake of more than 14 units per week (1 standard unit = 360 mL of beer or 150 mL of 12% wine or 45 mL of 40% spirits) within 6 months prior to screening.
- •Subjects who smoked > 5 cigarettes/day within 3 months prior to screening or who cannot stop using any tobacco products during the study.
- •Subjects with a history of allergy to ≥ 2 drugs, or known hypersensitivity or intolerance to the IMP or similar products and their excipients.
- •Presence of any suspected and/or definitively diagnosed malignancy at screening; or patients diagnosed with other malignancies within 5 years;
- •Previous or current medical history of cardiovascular, hematological, respiratory, digestive, urinary, endocrine/metabolic, neurological, or psychiatric disorders that, in the investigator's judgment, may affect the study outcomes.
- •History of acute or chronic pancreatitis, biliary/gallbladder diseases , or pancreatic injury.
- •Major surgery (including but not limited to procedures requiring general anesthesia) within 3 months prior to screening; or history of organ transplantation (except corneal transplantation performed more than 4 months prior to screening); or incomplete recovery from illness, trauma, or surgery at screening (e.g., significant impairment in daily living or working capacity compared to pre-illness/injury/surgery status); or planned surgery during the study period.
- •Blood donation or significant blood loss (> 400 mL), or blood transfusion in the 3 months prior to screening.
- •Presence of any clinically significant abnormalities in 12-lead electrocardiogram, vital signs (blood pressure, respiration, pulse rate, body temperature), physical examination, imaging examination, or laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, serum amylase, serum lipase, calcitonin) as determined by the investigator at screening..
- •Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody infection at screening.
- •History of organ transplantation, or acquired or congenital immune system disorders.
- •Participation in a clinical study of another investigational medicinal product (IMP), surgery, or device within 3 months before screening, or within 5 half-lives of the previous IMP (whichever is longer). Or plan to participate in another clinical study of an IMP, surgery, or device before completing all scheduled assessments in the clinical study.
- •Subjects who have used GLP-1 receptor agonists or drugs with the mechanism of action of GLP-1R agonists.
- •Subjects who are allergic to any food or have specific dietary requirements and cannot adhere to a standardized diet.
- •History of needle or blood phobia, or difficulty with blood collection; or inability/unwillingness to undergo repeated venipuncture.
- •Subjects who were considered not suitable for the clinical study due to other reasons at the discretion of the investigator.
研究组 & 干预措施
GZR102 injection
Experimental
Participants will get a single dose of GZR102 injection （fixed-ratio combination of GZR4 and GZR18）.
干预措施: GZR102 injection (Drug)
GZR4 injection
Active Comparator
Participants will get a single dose of GZR4 injection
干预措施: GZR18 injection (Drug)
GZR18 injection
Active Comparator
Participants will get a single dose of GZR18 injection
干预措施: GZR4 injection (Drug)
结局指标
主要结局
AUC0-t
时间窗: Day 36 (end of period)
Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
次要结局
- AUC0-inf(Day 36 (end of period))
- TEAEs(Day 36 (end of period))
- Hypoglycemia(Day 36 (end of period))
- Immunogenicity(Day 36 (end of period))
- Cmax(Day 36 (end of period))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DMType 1 Diabetes MellitusNCT03176524Adocia27
已完成
1 期
A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy VolunteersSolid TumorsNCT03258515AstraZeneca45
终止
1 期
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult ParticipantsHealthy VolunteersNCT03381144Genentech, Inc.66
终止
1 期
Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus SubjectsDiabetes MellitusNCT01755442Amgen5
招募中
3 期
A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric CancerGastric CancerNCT04139135Shanghai Henlius Biotech642