Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMC-003 for Injection in Healthy Postmenopausal Women
Led by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Updated on 2025-12-15
56
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
this study is a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMC-003 for injection in healthy postmenopausal women.
CONDITIONS
Official Title
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMC-003 for Injection in Healthy Postmenopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 45 to 75 years old
- Postmenopausal with spontaneous amenorrhea for at least 12 months, or 6 months with elevated serum FSH, or bilateral oophorectomy for 6 weeks or more
- Weight at least 45 kg and BMI between 18.0 and 30.0 kg/m2
- Normal physical exam, vital signs, ECG, and lab tests or abnormalities without clinical significance
- Able to understand the trial, communicate with researchers, follow regulations, and provide informed consent
You will not qualify if you...
- Clinically significant diseases or abnormalities affecting safety or pharmacokinetics
- Active bleeding or history of bleeding disorders within 6 months
- History of malignant tumors
- History of thrombosis, cerebral infarction, or myocardial infarction
- Intolerance to blood draws or history of fainting from venipuncture
- History of tuberculosis or severe infection within 3 months
- Severe allergies or known allergies to test drug or similar drugs
- Use of prescription drugs or herbal medicines within 4 weeks, or OTC supplements within 2 weeks before administration
- Use of drugs affecting bone metabolism within 6 months or expected use during trial
- Use of teriparatide or drugs affecting coagulation within 4 weeks
- Blood donation or loss of 400 mL or more within 3 months
- Major surgery within 3 months or planned during trial
- Heavy smoking (5 or more daily cigarettes) or inability to stop tobacco use
- Alcohol consumption above defined limits or unwillingness to stop during trial
- Excessive caffeine consumption (more than 8 cups daily) within 3 months
- History of drug abuse or positive drug screening
- Previous use of drugs targeting the same target
- Participation in other clinical trials within 3 months
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Inability to avoid substances affecting liver enzymes during trial
- Other investigator-determined reasons making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chengdu Xinhua hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
C
Chunyan Yuan, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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