Actively Recruiting
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Food Effects of IMM-H014 in Healthy Adults
Led by Changchun Intellicrown Pharmaceutical Co. LTD · Updated on 2025-04-11
138
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of IMM-H014, an oral drug, in healthy adults aged 18 to 45 years. The trial focuses on how the drug behaves in the body when taken on an empty stomach and after a high-fat, high-calorie meal. This randomized, double-blind, placebo-controlled phase 1 study includes three parts: single ascending dose, multiple ascending dose, and food effect evaluation. Participants will receive IMM-H014 or a placebo tablet orally once daily under fasting conditions. The single ascending dose part tests increasing doses from 12.5 mg up to 325 mg in different groups. The multiple ascending dose part involves daily doses for seven days, ranging from 37.5 mg to 225 mg. The food effect part studies the drug's pharmacokinetics after fasting and after a high-fat meal, with a seven-day washout period between treatments. Throughout the study, participants will undergo monitoring for adverse events, physical exams, vital signs, ECGs, and laboratory tests. Researchers will measure drug levels in the blood and observe any changes from baseline. The primary outcomes include safety and tolerability up to about 18 days depending on the study part. Participation will last up to 18 days, including dosing and follow-up assessments.
CONDITIONS
Brief 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...
- Volunteers able to give informed consent and complete the study per protocol
- Use effective contraception from screening start through last drug administration
- Age between 18 and 45 years, male and female
- Male weight at least 50 kg, female weight at least 45 kg
- Body mass index between 18 and 28 kg/m2
- Vital signs and physical exam normal or not clinically significant abnormal
You will not qualify if you...
- History of drug allergy or related allergic diseases
- Use of prescription, over-the-counter, herbal medicines, or health products within 2 weeks before screening
- Clinically significant abnormalities in lab tests, ultrasound, chest X-ray, or medical history within 6 months
- Diet or activities affecting drug metabolism within 7 days before screening
- Family history of serious heart rhythm disorders or sudden unexplained death before age 40
- Electrolyte imbalances that are clinically significant
- Abnormal ECG or QTcF greater than 450 ms
- Reduced kidney function with creatinine clearance below 90 mL/min
- Active or chronic gastrointestinal diseases or relevant surgery
- Major surgery within 6 months or planned during the study
- Participation in other clinical trials within 3 months before screening
- Blood donation or significant blood loss over 450 mL within 3 months
- History of alcohol abuse or positive alcohol test
- Smoking more than 5 cigarettes per day within 3 months
- History of drug abuse or positive drug screening
- Special diet requirements not compatible with study diet
- Difficulty swallowing
- Lactating females or positive pregnancy test
- Acute illness or medication use between screening and dosing
- Recent intake of caffeine, chocolate, or alcohol before dosing
- Investigator judgment deeming unsuitability for the study
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 18 days depending on the dosing part
Participants receive oral IMM-H014 or placebo under fasting or fed conditions in three parts: single ascending dose, multiple ascending dose for 7 days, and food effect with two treatment periods separated by a 7-day washout.
Multiple visits including dosing and assessment visits during up to 18 days
Duration - Up to 11 days after last dose
Participants are monitored for adverse events, vital signs, physical exams, ECG, and laboratory tests after dosing completion.
Several post-treatment visits for safety and pharmacokinetic assessments
Trial Site Locations
Total: 1 location
1
The first Bethune hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
S
Shiqi Bai
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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