NCT07828197进行中（未招募）1 期
A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate the relative bioavailability of a single subcutaneous injection of HDM1005 solution at different injection sites (upper arm and thigh)by using the abdomen subcutaneous injection as a control.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 55 years (inclusive), regardless of gender.
- •Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive).
- •In the investigator's opinion, the participants do not have any clinically significant abnormal findings based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening.
- •Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions.
排除标准
- •Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- •History of chronic pancreatitis, or an episode of acute pancreatitis within 3 months prior to screening.
- •History of acute cholecystitis within 3 months prior to screening.
- •Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening.
- •Presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable.
- •History of specific allergy (such as asthma, urticaria, eczema, etc.) or allergic constitution; or known intolerance or allergy to any component of the investigational drug or GLP-1 receptor (GLP-1R) agonists; or have a history of severe drug allergies.
- •Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study.
- •Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing.
- •History of drug abuse or positive urine drug test at screening.
- •Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications.
- •Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
- •Female participants who are breastfeeding or pregnant.
- •History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture.
- •Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.
研究组 & 干预措施
Cohort 1
Experimental
Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at abdomen.
干预措施: HDM1005 (Drug)
Cohort 3
Experimental
Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at thigh.
干预措施: HDM1005 (Drug)
Cohort 2
Experimental
Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at upper arm.
干预措施: HDM1005 (Drug)
结局指标
主要结局
Cmax
时间窗: Up to Day 29
Maximum observed concentration
AUC(0-t)
时间窗: Up to Day 29
Area under the curve from time 0 to t hour
AUC(0-∞)
时间窗: Up to Day 29
Area under the curve from time 0 hour to ∞
次要结局
- Tmax(Up to Day 29)
- t1/2(Up to Day 29)
- CL/F(Up to Day 29)
- Vz/F(Up to Day 29)
- Adverse events (AEs)(Up to Day 29)
研究者
研究点 (1)
Loading locations...
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