RecruitingPhase 1

The Pharmacokinetics and Pharmacodynamics Study of Evategrel CG-0255 Besylate）and Plavix® in Healthy Participants

United States136 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 months after the last dose of the study treatment (CG-0255 Besylate or Plavix®). The male partner of a female participant also needs to use condoms during this period.
. 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 sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal ligation) at least 3 months prior to dosing.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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.

Timeframe: Day 1 (LD) and Day 7 (MD)

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.

Timeframe: Day 1 (LD) and Day 7 (MD)

Trial details

NCT IDNCT07619885

SponsorShanghai CureGene Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Isabel Pino

305-547-5813 Isabel.pino@syneoshealth.com

View on ClinicalTrials.gov More Acute Coronary Syndromes (ACS) trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 months after the last dose of the study treatment (CG-0255 Besylate or Plavix®). The male partner of a female participant also needs to use condoms during this period.
. 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 sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal ligation) at least 3 months prior to dosing.

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.

Timeframe: Day 1 (LD) and Day 7 (MD)

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.

Timeframe: Day 1 (LD) and Day 7 (MD)