IPG1094 first-in-human look at safety and how the drug moves in the body (Phase 1)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm Phase 1 trial enrolls 24 healthy Chinese adults to evaluate the pharmacokinetics, safety, and tolerability of IPG1094 tablets. The study has two parts: Part A uses a crossover design to compare fasting versus post-meal administration of a 200 mg dose with intensive blood sampling; Part B assesses multiple-dose PK by giving 200 mg twice daily for 10 days to observe drug exposure and accumulation. Safety monitoring includes labs, ECGs, adverse events, and follow-up assessments. No placebo or blinding is used.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female healthy Chinese participants aged 18 to 50 years (inclusive).
2. Comprehensive assessments including physical examination, vital signs, 12-lead ECG, chest X-ray and laboratory tests are normal or with abnormalities judged not clinically significant by the investigator.
3. Body weight: Male ≥50.0 kg, Female ≥45.0 kg; Body Mass Index (BMI) ranges from 19.0 to 26.0 (inclusive). BMI = Weight(kg) / Height(m)².
4. Female participants are non-pregnant and non-lactating.
5. Participants have no pregnancy plan and no sperm/egg donation plan from 2 weeks before screening to 6 months after the end of the study, and agree to use effective contraception during this period.
6. Voluntarily sign the written informed consent form, and fully understand the trial content and potential adverse reactions.

Exclusion Criteria:

1. History of severe cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, psychiatric or other systemic diseases with clinical significance.
2. QTcF interval \>450 ms (male) or \>470 ms (female).
3. History of recurrent headache, nausea or vomiting.
4. Blood loss ≥400 mL within 3 months before screening, or plan to donate blood during the study.
5. History of orthostatic hypotension or dysphagia.
6. History of gastrointestinal diseases affecting drug absorption.
7. Lactose intolerance, special dietary restrictions, or unable to follow unified diet requirements during the trial.
8. History of drug/food allergy, drug abuse or alcohol abuse.
9. Heavy smoking, excessive intake of tea, coffee or caffeinated beverages within 3 months before screening.
10. Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening.
11. Use of drugs affecting liver metabolism or gastrointestinal environment within 30 days before screening.
12. Intake of citrus fruits/juices within 5 days before screening or during the trial.
13. Participated in other clinical trials within 3 months before screening.
14. Positive result of urine drug screen or breath alcohol test at admission.
15. Difficulty in venous blood collection, history of syncope during blood collection.
16. Acute illness before screening, or other conditions judged inappropriate for participation by the investigator.

Where it's running

• Shanghai Xuhui Central Hospital
  Shanghai, Xuhui, China Recruiting

Study contacts

• Study coordinator: Anzhu Yu
• Email: azyu@immunophage.com.cn
• Phone: +86-21-34782827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.