A Randomized, Double Blind, Placebo Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of IBI3046 in Chinese Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Event
研究概览
简要总结
This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female;
- •2.At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²;
- •3.Body weight change ≤ 5 % within 3 months prior to screening ;
- •4.Female participants of child bearing potential and male participants whose partners are of child bearing potential must agree to use highly effective contraceptive methods during the study and for 6 months after the last study drug administration. For female participants of child bearing potential, the pregnancy test result must be negative at screening. Female participants shall not breast feed. Male / female participants must be willing to refrain from sperm / oocyte donation during the study and for 6 months after the last study drug administration;
- •5.Able to understand study procedures and requirements, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.
排除标准
- •1. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases.
- •2. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening.
- •3. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening.
- •4. Positive screening results for infectious pathogen markers.
- •5. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
- •6. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
- •7. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
- •8. History of malignant tumors (excluding partial skin cancers) within 5 years.
- •9. Positive screening results for infectious pathogen markers.
- •10. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
- •11. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
- •12. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
- •13. History of malignant tumors (excluding partial skin cancers) within 5 years.
研究组 & 干预措施
Part1-SAD Placebo Control Group
Subjects receive single-dose matching placebo for IBI3046 in Part1 SAD phase, across 5 corresponding cohorts.
干预措施: placebo (Drug)
Part3-Combination Background Drug + IBI3046 Group
All subjects receive active reference drug first, followed by administration of IBI3046 across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD.
干预措施: IBI3046 (Drug)
Part4-Combination: Continuous Reference Drug with Intermittent Placebo Control Group
All subjects receive continuous active reference drug. Matching placebo for IBI3046 is administered at corresponding time points across 2 cohorts in Part4 combination phase.
干预措施: placebo (Drug)
Part4-Combination: Continuous Reference Drug with Intermittent IBI3046 Treatment Group
All subjects receive continuous active reference drug. IBI3046 is administered at different time points across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD.
干预措施: IBI3046 (Drug)
Part3-Combination: Reference Drug followed by Placebo Control Group
All subjects receive active reference drug first, followed by matching placebo for IBI3046 across 2 corresponding cohorts in Part3 combination phase.
干预措施: placebo (Drug)
Part2-MAD Placebo Control Group
Subjects receive matching placebo for IBI3046 in Part2 MAD phase, across 3 corresponding cohorts.
干预措施: placebo (Drug)
Part2-MAD IBI3046 Treatment Group
Subjects receive multiple ascending repeated doses of IBI3046 across 3 different dose cohorts, to evaluate safety, tolerability and steady-state pharmacokinetics.
干预措施: IBI3046 (Drug)
Part1-SAD IBI3046 Treatment Group
Subjects receive single ascending doses of IBI3046 across 5 different dose cohorts, to evaluate safety, tolerability and pharmacokinetics.
干预措施: IBI3046 (Drug)
结局指标
主要结局
Number of participants with Adverse Event
时间窗: up to Day 169 for SAD;up to Day 225 for MAD
Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
时间窗: up to Day 169 for SAD;up to Day 225 for MAD
Systolic blood pressure will be measured and recorded at each specified time point
Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
时间窗: up to Day 169 for SAD;up to Day 225 for MAD
diastolic blood pressure will be measured and recorded at each specified time point
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
时间窗: up to Day 169 for SAD;up to Day 225 for MAD
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be
Number of participants with clinically significant changes in physical examination results；
时间窗: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with abnormal ECG changes before and after administration in each dose group
时间窗: up to Day 169 for SAD;up to Day 225 for MAD
Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.
次要结局
- renal clearance (CLr)(up to Day 3 for SAD;up to Day 57 for MAD)
- Fraction of dose excreted in urine(Fe)(up to Day 3 for SAD;up to Day 57 for MAD)
- Immunogenicity characteristics of IBI3046(up to Day 169 for SAD;up to Day 225 for MAD)
- Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight.(up to Day 169 for SAD;up to Day 225 for MAD)
- Area Under the Curve (AUC) of the serum concentration-time profile(up to Day 3 for SAD;up to Day 57 for MAD)
- Maximum Concentration (Cmax) of the drug in serum(up to Day 3 for SAD;up to Day 57 for MAD)
- time to maximum concentration (Tmax)(up to Day 3 for SAD;up to Day 57 for MAD)
- Elimination Half-life (t1/2)(up to Day 3 for SAD;up to Day 57 for MAD)
- Amount of drug excreted in urine (Ae)(up to Day 3 for SAD;up to Day 57 for MAD)