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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM0811 | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), including type, incidence, grade (assessed according to NCI-CTCAE V5.0 criteria) | 7 days after final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration(Cmax) of SIM0811 in serum | 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 | Within 1-2 weeks of final blood sample collection |
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Inclusion Criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhibiao song | Contact | 86-13641133681 | songzhibiao@simcere.com | |
| wei zhao | Contact | 0531-82169023 | hao4wei2@haotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| yuguo chen | Qilu Hospital of Shandong University | Principal Investigator |
| wei zhao | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250100 | China |
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| Placebo | Drug | 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). |
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| Area Under the Concentration-time Curve from Time 0 to Infinity of SIM0811in serum | Within 1-2 weeks of final blood sample collection |
| Elimination Half-Life (T1/2) of SIM0811 in serum | Within 1-2 weeks of final blood sample collection |