Study of Evategrel CG-0255 Besylate and Plavix® in Healthy Participants
This study is comparing two medications, CG-0255 Besylate and Plavix® (clopidogrel), in healthy volunteers. Researchers want to understand how your body processes these drugs (pharmacokinetics or PK) when given as a starting dose and a regular daily dose. CG-0255 Besylate is a new investigational drug similar to Plavix®, which is used for conditions like heart attacks and strokes. This study aims to see if CG-0255 Besylate works similarly to Plavix® in healthy people. You can join if you are a healthy adult between 18 and 55 years old with a BMI between 18 and 32. The study plans to enroll 136 participants.
- Study design
- This is a randomized, open-label study comparing CG-0255 Besylate and Plavix® in healthy participants. It plans to enroll 136 participants.
- What's involved
- Participants will receive CG-0255 Besylate (as an injection or capsule) or Plavix® (as a capsule) as a loading dose and maintenance dose. The study measures drug levels on Day 1 (loading dose) and Day 7 (maintenance dose).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for the study are taken on Day 1 and Day 7.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07619885
The Pharmacokinetics and Pharmacodynamics Study of Evategrel CG-0255 Besylate）and Plavix® in Healthy Participants
Recruiting
PHASE1Ages 18–55InterventionalPreventionShanghai CureGene Pharmaceutical Co., Ltd.
~136 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:CG-0255 Besylate for InjectionCG-0255 Besylate CapsuleClopidogrel
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the PK of the active metabolite CG-0236 of CG-0255 Besylate and of Plavix® when they are administered as loading dose (LD) and maintenance dose (MD) in healthy participants.
Measured over Day 1 (LD) and Day 7 (MD)
+1 more outcome measured
Conditions
NCT07619885
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Syneos Health
Miami, Floridastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 screening and at the admission.
For female participants,
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. The female partner of a male participant also needs to use a highly effective contraceptive method during this period.
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.
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), aspartate aminotransferase (AST).
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 50 or over 90mmHg, HR less than 50 or over 100 bpm, or RR less than 10 or over 22 bpm) at screening.
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 (excluding drug products without significant systemic absorption at the discretion of the Investigator or designee), or depot injection or implant within 3 months prior to first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily).
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), and grapefruit or products containing grapefruit, or participants have engaged strenuous exercise or any other factors affecting drug absorption, distribution, metabolism and excretion within 7 days before the first dose of study treatment.
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, and amphetamine derivatives) within 3 months prior to screening.
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%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
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 48 hours prior to the first dose of study treatment, which may metabolize into caffeine or xanthine.
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 end of the study.
Participants deemed ineligible to participate in this study by the Investigator or designee.
Exclusion
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, administration of a biological product in the context of a clinical research study within 90 days (or 5 times half-life, whichever is longer) prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
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 including dysphagia, abdominal pain, abdominal distension, acid regurgitation, belching, hematemesis, bloody stool, anorexia, nausea, heartburn, and other symptoms that may increase the risk of bleeding, as determined by the Investigator or designee.
Any clinically significant diseases including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological, immunological, dermatological, malignant diseases, mental and nervous systems, and other related diseases or any other condition at the discretion of the Investigator or designee.
What this trial measures
- To compare the PK of the active metabolite CG-0236 of CG-0255 Besylate and of Plavix® when they are administered as loading dose (LD) and maintenance dose (MD) in healthy participants.Day 1 (LD) and Day 7 (MD)
Area under the plasma concentration-time curve from time 0 to the last quantifiable measurement time-point (AUClast)
- To compare the PK of the active metabolite CG-0236 of CG-0255 Besylate and of Plavix® when they are administered as loading dose (LD) and maintenance dose (MD) in healthy participants.Day 1 (LD) and Day 7 (MD)
Peak Plasma Concentration (Cmax)