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Tests treatment safety and results for Health, Subjective
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
What this study is testing
What is SIM0811?
SIM0811 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for health, subjective.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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 =...
- Female participants must avoid the menstrual period during the trial. participants of childbearing potential must commit to no plan for pregnancy...
- 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...
You likely can't join if
- 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...
- Presence of clinically significant history of cardiovascular, respiratory, endocrine, urinary, digestive, hematological, neurological, skin...
- Screening physical examination, vital signs, laboratory tests, or other examination results judged by the clinician as abnormal with clinical...
- Screening ECG findings judged as abnormal with clinical significance. Resting heart rate not within the range of 50 to 100 beats per minute...
- Risk factors for Torsades de Pointes, or family history (first-degree relatives - biological parents, siblings, or children) of short QT syndrome...
See the full eligibility criteria
- 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...
- 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...
- 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...
- Presence of clinically significant history of cardiovascular, respiratory, endocrine, urinary, digestive, hematological, neurological, skin, malignant tumor, infectious diseases, psychiatric disorders (e.g., seizures)...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- History of blood abnormalities or related diseases, bleeding tendency, bleeding disorders (hemophilia, intracranial hemorrhage, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.