Actively Recruiting
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-27
126
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese subjects. The trial consists of two parts: Part A is a single ascending dose (SAD) study, planning to enroll 54 Chinese healthy subjects; Part B is a multiple ascending dose (MAD) study, planning to enroll 72 Chinese overweight or obese subjects.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate and sign informed consent
- For SAD: Healthy adults aged 18 to 45 years
- For SAD: Male subjects weigh at least 50 kg, female at least 45 kg, with BMI 19.0 to 35.0 kg/m2
- For SAD: Normal or clinically insignificant abnormalities in vital signs, labs, ECG, and imaging
- For SAD: HbA1c less than 5.7% during screening
- For MAD: Adults aged 18 to 65 years
- For MAD: Overweight (BMI >24.0 to <28.0) with related conditions or obese (BMI ≥28.0)
- For MAD: Weight stable under diet and exercise for at least 12 weeks
- For MAD: HbA1c less than 6.5% during screening
- For all: Agree to use effective contraception during and 6 months after study
You will not qualify if you...
- Diagnosed diabetes (type 1, type 2, or other) before screening
- History or family history of medullary thyroid carcinoma or related conditions
- Acute, chronic, or suspected pancreatitis or prior pancreatectomy
- Any malignancy within 5 years except cured basal cell carcinoma
- Significant diseases affecting major organs or systems
- Diseases affecting gastric emptying or nutrient absorption
- Major surgery within 3 months before screening or planned during study
- Hypersensitivity to investigational product or components
- Use of medications affecting weight or glucose metabolism within 3 months
- Prior bariatric surgery
- Recurrent skin disorders or skin lesions at administration site
- Recent systemic glucocorticoid therapy
- Abnormal HbA1c or conditions interfering with its measurement
- Suicidal behavior or ideation within 6 months
- Use of GLP-1 receptor agonists within 6 months
- Excessive alcohol use or positive alcohol test
- History of drug abuse or positive drug screen
- Smoking more than 5 cigarettes per day recently
- Needle or blood phobia or difficulty with blood collection
- Positive tests for hepatitis B, C, HIV, or syphilis
- Abnormal liver enzymes, blood amylase/lipase, or serum calcitonin
- Abnormal fasting blood glucose or triglycerides
- Reduced kidney function (GFR <90 mL/min/1.73m2)
- Abnormal ECG or severe arrhythmias
- Use of strong enzyme inhibitors or inducers recently
- Consumption of foods/beverages affecting metabolism enzymes before dosing
- Recent significant blood donation or transfusion
- Participation in other clinical trials recently
- Acute illness or concomitant medication use before dosing
- Breastfeeding or positive pregnancy test
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Anhui Medical University is a Grade A Tertiary General
Hefei, Anhui, China, 230601
Actively Recruiting
Research Team
W
Wei Hu, Doctor of Medicine
CONTACT
Y
Yijun Du, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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