Actively Recruiting
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
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-05-20
72
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of single ascending doses of SIM0811 injection in healthy Chinese adults aged 18 to 45 years. This phase 1, randomized, double-blind, placebo-controlled study aims to understand how SIM0811 is processed in the body and to explore changes in thrombotic molecular markers after administration. The study enrolls both male and female participants who are healthy and meet specific weight and health criteria. The study uses a dose-escalation design with 7 cohorts, each receiving a single dose of SIM0811 or placebo intravenously through bolus plus infusion or bolus alone. Each cohort includes 8 participants (6 receiving SIM0811 and 2 receiving placebo). After dosing in each cohort, participants will be observed for 7 days to monitor safety before moving to the next dose level, pending review by a Safety Review Committee. Participants will undergo adverse event monitoring, vital signs checks, electrocardiograms, laboratory tests, and blood sample collections to measure SIM0811 plasma levels and thrombotic markers. The study will assess adverse events within 7 days after dosing and pharmacokinetic parameters within 1 to 2 weeks following the final blood collection. The total participation duration includes dosing and a 7-day safety observation period per cohort, with continued assessments for safety and drug behavior in the body.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Chinese male or female adults aged 18 to 45 years, not pregnant and not breastfeeding
- Male participants weighing at least 50 kg, female participants weighing at least 45 kg, all weighing no more than 90 kg
- Body Mass Index (BMI) between 19 and 26 kg/m² inclusive
- Female participants must avoid menstruation during the trial and commit to effective contraception if of childbearing potential
- Able to comply with study requirements and abstain from smoking and alcohol during the trial
- Willing to provide informed consent and communicate well with investigators
You will not qualify if you...
- History of drug allergy or allergic conditions including asthma, urticaria, eczema, or allergy to two or more substances
- Significant history of cardiovascular, respiratory, endocrine, urinary, digestive, hematological, neurological, skin, malignant tumor, infectious, psychiatric, or metabolic diseases
- Abnormal physical exam, vital signs, laboratory tests, or ECG judged clinically significant
- Risk factors or family history of serious heart rhythm disorders or sudden death
- Positive tests for Hepatitis B, Hepatitis C, syphilis, or HIV
- Excessive alcohol or tobacco use or inability to abstain during the trial
- History or positive screening for drug abuse within 5 years
- Use of prescription, OTC, herbal, or health products within 2 weeks before screening
- Recent surgery, trauma, or planned surgery during the trial
- Difficulty with blood sampling or history of phlebitis
- Recent blood donation or planned donation during the trial
- History of bleeding disorders or related conditions
- Pregnancy, lactation, positive pregnancy test, or recent unprotected sexual activity
- Recent vaccination or planned vaccination during the trial
- Participation in another clinical trial within 3 months prior
- Special dietary requirements preventing protocol adherence
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days after dosing
Participants receive a single dose of SIM0811 or placebo in a dose-escalation design. After administration, participants are observed for safety.
1 administration visit and daily observation visits for 7 days
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250100
Actively Recruiting
Research Team
Z
zhibiao song
W
wei zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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