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Healthy volunteers needed to test how common drugs interact with experimental medicine

NCT ID NCT07357610

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study looks at how three common drugs (itraconazole, rifampin, and midazolam) affect the levels of an experimental drug called SIM0270 in the body. About 60 healthy Chinese adults aged 18 to 55 will take part. The goal is to gather safety and drug interaction information, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The participant fully understand the test content, process and possible adverse reactions, voluntarily sign informed consent, have good communication with the researchers, and can complete all the test procedures in accordance with the protocol. * Cohorts 1 and 2: healthy male and female participants aged ≥ 18 and ≤ 55 years; Cohort 3: healthy male participants aged ≥ 18 and ≤ 55 years. * Male participants weigh ≥ 50 kg; Female participants weigh ≥ 45 kg; Body mass index ≥ 19 kg/m2 and ≤ 26 kg/m2. * Cohorts 1 and 2: all female participants of childbearing potential and male participants with partners of women of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent; Cohort 3: male participants with partners of women of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent. Exclusion Criteria: Past/Ongoing Medical History * Neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, skeletal-muscular disorders, especially hepatic and renal insufficiency, or any other disease and condition that may affect the results of the study or the safety of the participants. * History of dysphagia or any gastrointestinal disorder affecting drug absorption. * Presence of risk factors for Torsade de Pointes (e.g., history of heart failure, hypokalemia, family history of QT prolongation syndrome), or other clinically significant abnormalities judged by the study doctor (including but not limited to: complete left bundle branch block; right bundle branch block; first-, second-, or third-degree heart block; sick sinus syndrome or previous history of myocardial infarction). * History of active or latent tuberculosis. * History of malignancy. Except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer (disease-free interval of at least 5 years). * Any acute or chronic condition that, in the opinion of the investigator, would limit the ability of participants to complete and/or participate in this clinical study. Surgical history • Those who have undergone major surgery within 6 months prior to screening or are scheduled to undergo surgery during the study and are judged by the investigator to be inappropriate for enrollment. History of allergy • Allergic to the study drug or any component of the study drug, with a history of specific allergies (asthma, urticaria, eczema, etc.) or allergic constitution (e.g., those allergic to two or more drugs, food such as milk and pollen). Medication history * Use of hormone replacement therapy or selective estrogen mediators within 1 year prior to screening. * Use or planned use of any drug/product within 4 weeks prior to screening that would alter the process of drug absorption, metabolism, or elimination. * Use of any prescription drugs/products within 2 weeks prior to screening or over-the-counter medications (including vitamins, minerals, phytotherapies, herbal and botanical preparations) within 1 week prior to screening. Screening or Baseline Examinations * Laboratory tests, physical examination, vital signs, 12-lead electrocardiogram, chest anterolateral film, abdominal B-ultrasound results were abnormal and clinically significant as judged by the investigator. * Screening (mean) or baseline ECG heart rate \< 60 beats/min or \> 100 beats/min, QTcF interval \> 450 ms. * Women of childbearing potential who have a positive pregnancy test or are pregnant or lactating (see Appendix 1 for definitions of women of non-childbearing potential). * Positive tests for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, treponema pallidum antibody. * History of drug abuse or positive drug abuse screening. * Regular drinkers, i.e., on average, more than 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) within 3 months prior to screening or during the screening period to the first dose; Or alcohol breath test positive. * Those who smoke more than 5 cigarettes per day within 3 months prior to screening or who cannot quit during the trial. * Participation in any drug clinical trial as a participant and taking study drug or medical device intervention within 3 months prior to screening. * Consumption of grapefruit or grapefruit-related citrus (e.g., grapefruit) fruit or juice within 1 week prior to screening, or use of alcoholic or caffeinated food or beverages within 72 h prior to screening. * Those who have special requirements for diet and cannot comply with the diet provided and corresponding regulations. * Those who have difficulty in venous blood collection, or have a history of fainting blood and needle sickness, or who cannot tolerate venous indwelling needle blood collection. * Those who have donated blood or lost more than 200 mL of blood within 3 months prior to screening, or have received blood transfusions or blood products within 2 months. * Participants have other conditions that are not suitable for participation in the study, or participants may not be able to complete the study for other reasons

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shandong University of Qilu Hospital

    RECRUITING

    Jinan, Shandong, 250100, China

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