Actively Recruiting
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Trial to Evaluate Safety, Tolerability, and Pharmacokinetics 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection in both healthy adults and overweight or obese subjects. This Phase 1 clinical trial uses a randomized, double-blind, placebo-controlled, dose-escalation design to study the effects of a single dose in healthy subjects and multiple doses in overweight or obese participants. The trial is conducted at a single center and aims to better understand how the drug behaves and is tolerated in these different populations. The study is divided into two parts: Part A involves a single ascending dose (SAD) study with 54 healthy Chinese adults receiving either HEC-007 Injection or placebo administered once. Part B is a multiple ascending dose (MAD) study with 72 overweight or obese Chinese subjects receiving multiple doses of HEC-007 Injection or placebo. The dosing schedules vary between the single and multiple dose administrations to evaluate different aspects of the drug’s pharmacological profile. Participants will be monitored from screening through up to day 43 or day 113 post-dose depending on the study part. Assessments include vital signs, physical exams, laboratory tests, ECGs, imaging, and questionnaires about body weight, waist circumference, fasting plasma glucose, insulin levels, and blood lipids. Researchers will track adverse events, drug concentration over time, and changes from baseline in metabolic and anthropometric measures to evaluate safety and drug effects. The total participation time varies based on the study phase and dose escalation.
CONDITIONS
Brief 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 must understand and agree to the study procedures and sign informed consent.
- For SAD: Healthy adults aged 18 to 45 years, any sex.
- For SAD: Males weigh at least 50 kg, females at least 45 kg, with BMI 19.0 to 35.0 kg/m2.
- For MAD: Adults aged 18 to 65 years, any sex.
- For MAD: Overweight or obese with BMI ≥28.0 kg/m2 or BMI 24.0-28.0 kg/m2 plus specific related health conditions.
- Stable weight with less than 5% change over at least 12 weeks of diet and exercise.
- Willing to use effective contraception during and for 6 months after treatment.
- HbA1c less than 5.7% for SAD, less than 6.5% for MAD during screening.
You will not qualify if you...
- Diagnosis of type 1 or type 2 diabetes before screening.
- History or family history of certain thyroid cancers or genetic predisposition.
- Acute or chronic pancreatitis or prior pancreatectomy.
- Malignancy within 5 years before screening, except certain skin cancers.
- Significant diseases including gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders.
- Conditions affecting gastric emptying or nutrient absorption.
- Major surgery within 3 months before screening or planned during study.
- Hypersensitivity to study drug or related substances.
- Use of medications affecting weight or glucose metabolism recently.
- History of bariatric surgery.
- Recurrent skin disorders or skin lesions at administration site.
- Recent systemic glucocorticoid therapy.
- Abnormal HbA1c measurement conditions.
- Suicidal behaviors or psychiatric disorders within 6 months.
- Recent use of specific agonist medications.
- Regular alcohol use exceeding study limits or positive alcohol test.
- History of drug abuse or positive drug screen.
- Smoking over 5 cigarettes per day recently or inability to abstain during sampling.
- Needle or blood phobia or difficulty in blood collection.
- Positive tests for hepatitis B, C, HIV, or syphilis.
- Abnormal liver enzymes or bilirubin.
- Abnormal blood amylase or lipase.
- Elevated serum calcitonin.
- Abnormal fasting blood glucose or triglycerides.
- Reduced kidney function.
- Abnormal heart electrical activity or severe arrhythmias.
- Use of strong liver enzyme inhibitors or inducers recently.
- Consumption of certain foods or beverages affecting metabolism prior to dosing.
- Recent significant blood donation or transfusion.
- Participation in other clinical trials recently.
- Acute illness or medication use from consent to first dose.
- Currently breastfeeding or pregnant females.
- Other factors deemed unsuitable by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 113 days post-dose
Participants receive either a single or multiple doses of HEC-007 injection or placebo according to their assigned group.
Multiple visits for dosing and assessments up to day 43 or day 113 depending on group
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
Y
Yijun Du, Doctor of Medicine
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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