Health, SubjectivePhase 1NCT07345364
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Participants
A Phase 1 study testing SIM0811 in people with Health, Subjective, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study plans to set up 5 dose groups across 7 cohorts, including intravenous bolus plus infusion administration as well as intravenous bolus alone. The study plans to enroll 8 participants per cohort (investigational drug: placebo = 6:2), including both males and females, totaling 56 healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- SIM0811
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2026to 18 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese male or female adults aged 18 to 45 years (inclusive), not pregnant and not breastfeeding.
- Male participants weight ≥50 kg, female participants weight ≥45 kg, all ≤90 kg. Body Mass Index (BMI) between 19 and 26 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
- Female participants must avoid the menstrual period during the trial. participants of childbearing potential must commit to no plan for pregnancy, sperm/egg donation within 2 weeks before screening and for 6 months after the last dose, and voluntarily adopt highly effective contraception (including partner).
- Able to complete the study according to protocol requirements and commit to abstaining from smoking and alcohol during the trial.
- Prior to the trial, have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial, voluntarily participate, can communicate well with the investigator, comply with all study requirements, and voluntarily sign the Ethics Committee-approved Informed Consent Form.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- History of drug allergy, or specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (e.g., allergy to two or more drugs, foods, pollen), or known allergy or significant intolerance to the investigational product or any of its components.
- Presence of clinically significant history of cardiovascular, respiratory, endocrine, urinary, digestive, hematological, neurological, skin, malignant tumor, infectious diseases, psychiatric disorders (e.g., seizures), metabolic abnormalities/dysfunction, etc.
- Screening physical examination, vital signs, laboratory tests, or other examination results judged by the clinician as abnormal with clinical significance (confirmed upon repeat assessment); OR presence of the following abnormal laboratory indicators: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine above the upper limit of normal (ULN); platelet count below the lower limit of normal (LLN); hyperkalemia, hypokalemia, hypercalcemia, or hypocalcemia judged by the investigator as abnormal and clinically significant; PT prolongation > ULN + 3s, TT prolongation > ULN + 3s, APTT prolongation > ULN + 10s, INR > 1.2, FIB < 1.5 g/L or > 4.0 g/L, D-Dimer above ULN.
- Screening ECG findings judged as abnormal with clinical significance. Resting heart rate not within the range of 50 to 100 beats per minute (exclusive of boundaries). QTcF interval > 470 ms (QTcF = QT/(RR)^0.33) or PR interval outside the range of 120 to 220 ms.
- Risk factors for Torsades de Pointes, or family history (first-degree relatives - biological parents, siblings, or children) of short QT syndrome, long QT syndrome, unexplained sudden death at a young age (≤40 years), drowning, or sudden infant death syndrome.
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- Positive screening results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Treponema pallidum specific antibody, or Human Immunodeficiency Virus (HIV) antibody.
- Average daily alcohol consumption exceeding 2 units in the 2 years prior to screening, or weekly alcohol consumption >14 units (1 unit alcohol ≈ 360 ml beer or 45 ml 40% spirits or 150 ml wine); consumption of any alcohol-containing product within 24 hours prior to investigational product administration; or inability to stop alcohol consumption during the trial; or positive alcohol breath test.
- Average daily cigarette consumption >5 in the 2 years prior to screening, or inability to stop using any tobacco products during the trial.
- Positive screening result for drug abuse, or history of drug abuse or use of narcotics within the past five years.
- Use of any prescription drugs, over-the-counter (OTC) drugs, Chinese herbal medicines, or health products within 2 weeks prior to screening and during screening, or within 5 half-lives of such drugs.
- Any surgery or trauma within 1 year prior to investigational product administration that may affect trial safety or drug disposition, and judged by the investigator to be of current clinical significance; OR planned surgery during the trial or within 7 days after trial completion.
- Difficulty with venous blood sampling, history of hematophobia or trypanophobia, or intolerance to indwelling venous catheter for blood sampling; OR history of phlebitis.
- Blood donation or blood loss >200 ml within 3 months prior to screening, or receipt of blood transfusion or blood products within 4 weeks; OR plan to donate blood during the trial or within 3 months after trial completion.
- History of blood abnormalities or related diseases, bleeding tendency, bleeding disorders (hemophilia, intracranial hemorrhage, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.); OR arterial puncture at a site difficult to compress for hemostasis within 1 week prior; history of aneurysm.
- Pregnancy, lactation, positive pregnancy test, sexual intercourse without protocol-required contraception within 2 weeks prior to screening, or planned pregnancy.
- Vaccination within 1 month prior to screening, or planned vaccination during the trial / within 2 weeks after the last investigational product dose.
- Participation in another drug or medical device clinical trial within 3 months prior to screening, or planned participation in another clinical trial during this study.
- Special dietary requirements and unable to accept unified diet and schedule arrangements.
- Other conditions judged by the clinical research physician as unsuitable for participation, or other reasons the participant may be unable to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study plans to set up 5 dose groups across 7 cohorts, including intravenous bolus plus infusion administration as well as intravenous bolus alone. The study plans to enroll 8 participants per cohort (investigational drug: placebo = 6:2), including both males and females, totaling 56 healthy participants. The study begins with dose-escalation enrollment starting from Cohort 1. Each cohort receives a single dose, sequentially completing Cohorts 2, 3, 4, 5, 6, and 7. After each cohort's dosing is completed, a 7-day observation period is conducted for safety evaluation. If the termination criteria are not met, the study may proceed to the next dose level following assessment by the Safety Review Committee. By collecting adverse events, as well as abnormal indicators from vital signs, electrocardiograms, and laboratory tests, and collecting blood samples at planned time points to measure SIM0811 plasma concentration and thrombotic molecular markers, the study aims to evaluate the tolerability and safety of SIM0811 injection in Chinese healthy adult participants, characterize its pharmacokinetic profile after single-dose administration, and explore the change curves of thrombotic molecular markers (plasmin-α2 antiplasmin complex PIC, fibrin degradation products FDP)
- Conditions
- Health, Subjective
- Being tested
- SIM0811, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0811Drug
The study will employ a dose-escalation design starting from Cohort 1. Each cohort will receive a single administration, sequentially completing Cohort 2, Cohort 3, Cohort 4, Cohort 5 , Cohort 6, Cohort 7,Cohort 8 and Cohort 9. After administration in each cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC).
PlaceboDrug
The study will employ a dose-escalation design starting from Cohort 1. Each cohort will receive a single administration, sequentially completing Cohort 2, Cohort 3, Cohort 4, Cohort 5 , Cohort 6, Cohort 7 Cohort 8and Cohort 9. After administration in each cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC).
| Study group | Role | What they receive |
|---|---|---|
| SIM0811 | Experimental | The study is designed to include 6 dose groups across 9 cohorts, with two administration methods: intravenous bolus plus intravenous infusion, and intravenous bolus alone. Each cohort will enroll 6 participants to receive SIM0811 The study will employ a dose-escalation design starting from Cohort 1. After administration in each dose group/cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC) Receives: Drug: SIM0811 |
| Placebo | Placebo comparator | The study is designed to include 7 dose groups across 9 cohorts, with two administration methods: intravenous bolus plus intravenous infusion, and intravenous bolus alone. Each cohort will enroll 2 participants to receive placebo The study will employ a dose-escalation design starting from Cohort 1. After administration in each dose group/cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs), including type, incidence, grade (assessed according to NCI-CTCAE V5.0 criteria)
Measured: 7 days after final dose
Secondary outcomes (4)
Peak plasma concentration(Cmax) of SIM0811 in serum
Measured: Within 1-2 weeks of final blood sample collection
Area Under the Concentration-time Curve from Time 0 to Time t of SIM0811 in serum
Measured: Within 1-2 weeks of final blood sample collection
Area Under the Concentration-time Curve from Time 0 to Infinity of SIM0811in serum
Measured: Within 1-2 weeks of final blood sample collection
Elimination Half-Life (T1/2) of SIM0811 in serum
Measured: Within 1-2 weeks of final blood sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start12 Jan 2026
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yuguo chen, Principal investigator, Qilu Hospital of Shandong Universitywei zhao, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345364
- Sponsor's protocol ID
- SIM0811-101
- Status last verified
- Oct 2026
- First submitted
- 26 Dec 2025
- Last updated
- 22 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Participants
- ClinicalTrials.gov ID
- NCT07345364
- Acronym / sponsor ID
- SIM0811-101
- Conditions
- Health, Subjective
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 15 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 plans to set up 5 dose groups across 7 cohorts, including intravenous bolus plus infusion administration as well as intravenous bolus alone. The study plans to enroll 8 participants per cohort (investigational drug: placebo = 6:2), including both males and females, totaling 56 healthy participants. The study begins with dose-escalation enrollment starting from Cohort 1. Each cohort receives a single dose, sequentially completing Cohorts 2, 3, 4, 5, 6, and 7. After each cohort's dosing is completed, a 7-day observation period is conducted for safety evaluation. If the termination criteria are not met, the study may proceed to the next dose level following assessment by the Safety Review Committee. By collecting adverse events, as well as abnormal indicators from vital signs, electrocardiograms, and laboratory tests, and collecting blood samples at planned time points to measure SIM0811 plasma concentration and thrombotic molecular markers, the study aims to evaluate the tolerability and safety of SIM0811 injection in Chinese healthy adult participants, characterize its pharmacokinetic profile after single-dose administration, and explore the change curves of thrombotic molecular markers (plasmin-α2 antiplasmin complex PIC, fibrin degradation products FDP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIM0811 | Experimental | Drug: SIM0811The study is designed to include 6 dose groups across 9 cohorts, with two administration methods: intravenous bolus plus intravenous infusion, and intravenous bolus alone. Each cohort will enroll 6 participants to receive SIM0811 The study will employ a dose-escalation design starting from Cohort 1. After administration in each dose group/cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC) |
| Placebo | Placebo comparator | Drug: PlaceboThe study is designed to include 7 dose groups across 9 cohorts, with two administration methods: intravenous bolus plus intravenous infusion, and intravenous bolus alone. Each cohort will enroll 2 participants to receive placebo The study will employ a dose-escalation design starting from Cohort 1. After administration in each dose group/cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Chinese male or female adults aged 18 to 45 years (inclusive), not pregnant and not breastfeeding.
- Male participants weight ≥50 kg, female participants weight ≥45 kg, all ≤90 kg. Body Mass Index (BMI) between 19 and 26 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
- Female participants must avoid the menstrual period during the trial. participants of childbearing potential must commit to no plan for pregnancy, sperm/egg donation within 2 weeks before screening and for 6 months after the last dose, and voluntarily adopt highly effective contraception (including partner).
- Able to complete the study according to protocol requirements and commit to abstaining from smoking and alcohol during the trial.
- Prior to the trial, have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial, voluntarily participate, can communicate well with the investigator, comply with all study requirements, and voluntarily sign the Ethics Committee-approved Informed Consent Form.
Key exclusion criteria (20 listed)
- History of drug allergy, or specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (e.g., allergy to two or more drugs, foods, pollen), or known allergy or significant intolerance to the investigational product or any of its components.
- Presence of clinically significant history of cardiovascular, respiratory, endocrine, urinary, digestive, hematological, neurological, skin, malignant tumor, infectious diseases, psychiatric disorders (e.g., seizures), metabolic abnormalities/dysfunction, etc.
- Screening physical examination, vital signs, laboratory tests, or other examination results judged by the clinician as abnormal with clinical significance (confirmed upon repeat assessment); OR presence of the following abnormal laboratory indicators: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine above the upper limit of normal (ULN); platelet count below the lower limit of normal (LLN); hyperkalemia, hypokalemia, hypercalcemia, or hypocalcemia judged by the investigator as abnormal and clinically significant; PT prolongation > ULN + 3s, TT prolongation > ULN + 3s, APTT prolongation > ULN + 10s, INR > 1.2, FIB < 1.5 g/L or > 4.0 g/L, D-Dimer above ULN.
- Screening ECG findings judged as abnormal with clinical significance. Resting heart rate not within the range of 50 to 100 beats per minute (exclusive of boundaries). QTcF interval > 470 ms (QTcF = QT/(RR)^0.33) or PR interval outside the range of 120 to 220 ms.
- Risk factors for Torsades de Pointes, or family history (first-degree relatives - biological parents, siblings, or children) of short QT syndrome, long QT syndrome, unexplained sudden death at a young age (≤40 years), drowning, or sudden infant death syndrome.
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 |
|---|---|---|
| SIM0811The study will employ a dose-escalation design starting from Cohort 1. Each cohort will receive a single administration, sequentially completing Cohort 2, Cohort 3, Cohort 4, Cohort 5 , Cohort 6, Cohort 7,Cohort 8 and Cohort 9. After administration in each cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC). | Drug | SIM0811 |
| PlaceboThe study will employ a dose-escalation design starting from Cohort 1. Each cohort will receive a single administration, sequentially completing Cohort 2, Cohort 3, Cohort 4, Cohort 5 , Cohort 6, Cohort 7 Cohort 8and Cohort 9. After administration in each cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC). | Drug | Placebo |
Primary outcome
Adverse events (AEs), including type, incidence, grade (assessed according to NCI-CTCAE V5.0 criteria)
Time frame: 7 days after final dose
4 secondary outcomes
Peak plasma concentration(Cmax) of SIM0811 in serum
Time frame: Within 1-2 weeks of final blood sample collection
Area Under the Concentration-time Curve from Time 0 to Time t of SIM0811 in serum
Time frame: Within 1-2 weeks of final blood sample collection
Area Under the Concentration-time Curve from Time 0 to Infinity of SIM0811in serum
Time frame: Within 1-2 weeks of final blood sample collection
Elimination Half-Life (T1/2) of SIM0811 in serum
Time frame: Within 1-2 weeks of final blood sample collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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. This study is not recruiting at the moment.
yuguo chen principal investigator
Qilu Hospital of Shandong University
wei zhao principal investigator
Qilu Hospital of Shandong University
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 SIM0811 in people with Health, Subjective, 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 22 Oct 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs), including type, incidence, grade (assessed according to NCI-CTCAE V5.0 criteria) (time frame: 7 days after final dose). 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 Oct 2026.