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New treatment option for Acute Coronary Syndromes (ACS)
Official title The Pharmacokinetics and Pharmacodynamics Study of Evategrel CG-0255 Besylate）and Plavix® in Healthy Participants
ClinicalTrials.gov ID: NCT07619885
What this study is testing
What is CG-0255 Besylate for Injection?
CG-0255 Besylate for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute coronary syndromes (acs).
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
- CG-0255 is a novel investigational prodrug of the active metabolite of Plavix®， but with different active metabolite conversion routes. This is a randomized, open-label and Plavix®-controlled study to compare the PK and PD of CG-0255 Besylate and Plavix® in healthy participants.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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 55. Healthy volunteers may be eligible.
You may be able to join if
- Participants must be fully informed about the study, willing to participate, and sign the informed consent document prior to any procedure.
- Healthy male and female participants, aged 18 to 55 years (inclusive) at time of signing informed consent form.
- Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) at screening and body weight between 45 and 120 kg (inclusive).
- Smoking \< 10 cigarettes (10-20 mg of nicotine/month) or equivalent amount of nicotine products per month within 6 months prior to screening and...
- Generally normal health, or abnormalities deemed non-clinically significant by the Investigator or designee based on medical history, physical...
You likely can't join if
- Difficulty with venous blood collection or a history of fainting upon seeing blood or needles.
- Clinically relevant drug intolerance or allergy or known or suspected hypersensitivity to any component of CG-0255 Besylate or Plavix®, or other...
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 times...
- Current or unresolved digestive tract diseases (dyspepsia, gastroesophageal reflux, gastro-hemorrhage, or digestive tract ulcer disease) within the...
- Any clinically significant diseases including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological...
- History of previous or current active bleeding (such as intracranial hemorrhage, gastrointestinal hemorrhage, urethral hemorrhage, hemoptysis...
See the full eligibility criteria
Who can join
- Participants must be fully informed about the study, willing to participate, and sign the informed consent document prior to any procedure.
- Healthy male and female participants, aged 18 to 55 years (inclusive) at time of signing informed consent form.
- Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) at screening and body weight between 45 and 120 kg (inclusive).
- Smoking \< 10 cigarettes (10-20 mg of nicotine/month) or equivalent amount of nicotine products per month within 6 months prior to screening and agree to abstain from tobacco and/or nicotine products during the study.
- Generally normal health, or abnormalities deemed non-clinically significant by the Investigator or designee based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests at the...
- For female participants,
- Woman of child-bearing potential (WOCBP) must be non-pregnant and non-lactating, and must agree to use highly effective contraceptive methods and abstain from egg collection or donation from the screening period to 3...
- Woman of non-childbearing potential (WONCBP) must be post menopausal (spontaneous amenorrhea for at least 12 consecutive months prior to dosing) with confirmation by documented FSH levels ≥40 mIU/mL; or surgically...
- Male participants considered fertile must agree to not plan to father a child, not donate sperm and take effective contraceptive methods from the screening period to 3 months after the last dose of the study treatment...
- Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the screening period to 3 months after the last dose of the study treatment.
- Participants must be able to communicate well with the Investigator or designee, as well as understand and adhere to the study's requirements.
What rules you out
- Difficulty with venous blood collection or a history of fainting upon seeing blood or needles.
- Clinically relevant drug intolerance or allergy or known or suspected hypersensitivity to any component of CG-0255 Besylate or Plavix®, or other related drugs.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 times half-life, whichever is longer) prior to the first dosing...
- Current or unresolved digestive tract diseases (dyspepsia, gastroesophageal reflux, gastro-hemorrhage, or digestive tract ulcer disease) within the past 6 months, or frequent (\> 1 time/week) digestive tract symptoms...
- Any clinically significant diseases including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological, immunological, dermatological, malignant diseases, mental and nervous...
- History of previous or current active bleeding (such as intracranial hemorrhage, gastrointestinal hemorrhage, urethral hemorrhage, hemoptysis, vitreous hemorrhage, bleeding caused by stool and hemorrhoids), transient...
- Hemoglobin \<120 g/L for males and \<110 g/L for females at screening.
- Medication history of NSAIDs (including Aspirin) or other drugs that may affect coagulation function (e.g, oral anticoagulants) within 4 weeks before the screening.
- Platelet count \< 120 × 10\^9/L at screening.
- Laboratory measures with values above the 1.5 × upper limits of normal (ULN) and deemed clinically significant by the Investigator or designee for the alanine aminotransferase (ALT), alkaline phosphatase (ALP)...
- Clinically significant ECG abnormalities (QTcF interval ≥ 450 ms for male, ≥ 470 ms for female (Fridericia's Correction)) or vital signs abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than...
- Major surgery within 3 months prior to the first dose of study treatment or plans for surgery during the study.
- Use of prescription, nonprescription or dietary supplements (e.g. food supplements and herbal supplements) within 14 days or 5 times the half life (whichever is longer) prior to the first dose of study treatment...
- Vaccinated within 14 days prior to the first dose of study treatment or planned to be vaccinated during the study.
- Consuming quinine containing products, including quinine water, tonic water bitter lemon, jello shots, any quinine preparations or Cinchona tree bark reparations (e.g., herbal medications containing Cinchona tree bark)...
- History of drug abuse within 1 year before screening, or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin...
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or at the admission.
- Positive pregnancy test or lactating female participant at screening or at the admission.
- Donation of plasma within 7 days prior to the first dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to the first dosing.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%...
- Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- Excessive drinking of tea, coffee, or caffeine-containing beverage (\>600 mg/day) within 30 days before screening; intake of caffeine- or xanthine rich foods or drinks (e.g., coffee, tea, chocolate, cola drinks) within...
- Positive screening for human immunodeficiency virus (HIV) antigen and antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening.
- Estimated glomerular filtration rate (eGFR) \<60 mL/min as calculated per CKD-EPI equation, at screening.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (including CYP2C19 inducers or inhibitors) within 30 days prior to the first study drug administration or 5 half-lives (whichever is longer) until the...
- Participants deemed ineligible to participate in this study by the Investigator or designee.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. 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.