Actively Recruiting
To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
Led by Changchun Intellicrown Pharmaceutical Co. LTD · Updated on 2025-04-11
138
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.
CONDITIONS
Official Title
To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily agree to participate and sign informed consent
- Use effective contraception methods from screening start to last drug administration
- Aged between 18 and 45 years, both male and female
- Male weight at least 50 kg, female weight at least 45 kg
- Body Mass Index (BMI) between 18 and 28 kg/m2
- Vital signs and physical exam results are normal or without clinically significant abnormalities
You will not qualify if you...
- History of drug allergy or allergic diseases like asthma or urticaria
- Use of any prescription, over-the-counter, herbal, or health products within 2 weeks before screening
- Clinically significant abnormalities in lab tests, ultrasound, chest X-ray, or other diseases within 6 months before screening
- Consumed diets affecting drug metabolism or had strenuous exercise within 7 days before screening
- Family history of certain heart rhythm disorders or sudden unexplained death
- Clinically significant abnormal electrolyte levels
- ECG abnormalities or prolonged QT interval
- Reduced kidney function (creatinine clearance below 90 mL/min)
- Chronic or active gastrointestinal diseases believed to affect drug processing
- Major surgery within 6 months before screening or planned during the study
- Participation in other clinical trials within 3 months prior to screening
- Blood donation or significant blood loss within 3 months prior to screening
- History of alcohol abuse or positive alcohol breath test
- Smoking more than 5 cigarettes per day in the past 3 months
- History of drug abuse or positive drug screening
- Special diet requirements that cannot be standardized
- Difficulty swallowing (dysphagia)
- Female subjects who are breastfeeding or pregnant
- Acute illness or use of medications between screening and drug administration
- Consumption of caffeine or chocolate within 24 hours before first dose
- Alcohol consumption or positive breath test within 24 hours before dosing
- Investigator's judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The first Bethune hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
S
Shiqi Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
13
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