Healthy Adult ParticipantsPhase 1SIM0270-104NCT07357610
An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
A Phase 1 study testing SIM0270, itraconazole and Rifampin in people with Healthy Adult Participants, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- SIM0270, itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 30 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong University of Qilu Hospital
Jinan, Shandong, 250100
Wei Zhao, PHD, +86 0531-82169023, zhao4wei2@hotmail.com
Rui Zhang, PHD
About this study
This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.
- Conditions
- Healthy Adult Participants
- Being tested
- SIM0270, itraconazole, Rifampin, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0270Drug
oral
itraconazoleDrug
oral
RifampinDrug
oral
midazolamDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI | Experimental | Cohort 1 is planned to enroll 16-20 healthy adult participants, both male and female Receives: Drug: SIM0270; Drug: itraconazole |
| Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270. | Experimental | Cohort 2 is planned to enroll 16-20 healthy adult participants, both male and female. Receives: Drug: SIM0270; Drug: Rifampin |
| Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol | Experimental | Cohort 3 is planned to enroll 16-20 healthy adult participants，male only Receives: Drug: SIM0270; Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 16-Day 30
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 16-Day 30
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 16-Day 30
Area under concentration-time curve from time 0 to tau (AUC0-tau) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 16-Day 30
Terminal half-life（t1/2）of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 16-Day 30
Maximum observed concentration (Cmax) of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 20-Day 32
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 20-Day 32
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants
Measured: Day 1-Day 13, Day 20-Day 32
Terminal half-life（t1/2）of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Measured: Day 1-Day 13, Day 20-Day 32
Maximum observed concentration (Cmax) of midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Measured: Day 1-Day 2, Day 11-Day 13
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of Midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Measured: Day 1-Day 2, Day 11-Day 13
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of Midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Measured: Day 1-Day 2, Day 11-Day 13
Terminal half-life（t1/2）of midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Measured: Day 1-Day 2, Day 11-Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357610
- Sponsor's protocol ID
- SIM0270-104
- Acronym
- SIM0270-104
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07357610
- Acronym / sponsor ID
- SIM0270-104 / SIM0270-104
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI | Experimental | Drug: SIM0270, Drug: itraconazoleCohort 1 is planned to enroll 16-20 healthy adult participants, both male and female |
| Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270. | Experimental | Drug: SIM0270, Drug: RifampinCohort 2 is planned to enroll 16-20 healthy adult participants, both male and female. |
| Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol | Experimental | Drug: SIM0270, Drug: midazolamCohort 3 is planned to enroll 16-20 healthy adult participants，male only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM0270oral | Drug | Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI, Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270., Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol |
| itraconazoleoral | Drug | Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI |
| Rifampinoral | Drug | Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270. |
| midazolamoral | Drug | Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol |
Primary outcome
Maximum observed concentration (Cmax) of SIM0270
Time frame: Day 1-Day 13, Day 16-Day 30
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270
Time frame: Day 1-Day 13, Day 16-Day 30
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270
Time frame: Day 1-Day 13, Day 16-Day 30
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration-time curve from time 0 to tau (AUC0-tau) of SIM0270
Time frame: Day 1-Day 13, Day 16-Day 30
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Terminal half-life（t1/2）of SIM0270
Time frame: Day 1-Day 13, Day 16-Day 30
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Maximum observed concentration (Cmax) of SIM0270
Time frame: Day 1-Day 13, Day 20-Day 32
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270
Time frame: Day 1-Day 13, Day 20-Day 32
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270
Time frame: Day 1-Day 13, Day 20-Day 32
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants
Terminal half-life（t1/2）of SIM0270
Time frame: Day 1-Day 13, Day 20-Day 32
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Maximum observed concentration (Cmax) of midazolam
Time frame: Day 1-Day 2, Day 11-Day 13
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of Midazolam
Time frame: Day 1-Day 2, Day 11-Day 13
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of Midazolam
Time frame: Day 1-Day 2, Day 11-Day 13
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Terminal half-life（t1/2）of midazolam
Time frame: Day 1-Day 2, Day 11-Day 13
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM0270, itraconazole and Rifampin in people with Healthy Adult Participants, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiuping Huang, Master (86+15060083948, huangqiuping@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) of SIM0270 (time frame: Day 1-Day 13, Day 16-Day 30). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.