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

Part of paid clinical trials in Miami, Florida.

Sponsor
Shanghai CureGene Pharmaceutical Co., Ltd.
Study ID
NCT07619885
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Coronary Syndromes (ACS)
  • Peripheral Arterial Disease
  • Recent Myocardial Infarction
  • Recent Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • CG-0255 Besylate for Injection — DRUG
    Calculate the dosage and number of vials required for a participant according to body weight. Reconstitute with 5 mL of sterile water for each 5 mg/vial to get clear solution for injection in 1 mg/mL (as CG-0255). The reconstituted CG-0255 Besylate for injection (1 mg/mL), must be further diluted in 100 mL normal saline infusion bag, following the instruction in the pharmacy manual.
  • CG-0255 Besylate Capsule — DRUG
    Orally administered as LD or MD with approximately 240 mL of water.
  • Clopidogrel — DRUG
    Orally administered as LD or MD with approximately 240 mL of water.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment A: CG-0255 oral for both Loading Dose (LD) and Maintenance Dose (MD)
    For Treatment A, participants will be administered with 3 mg CG-0255 Besylate capsules on Day 1. Subsequently, they will receive 0.75 mg CG-0255 Besylate capsules once daily from Days 2 to 7.
  • Experimental: Treatment B: CG-0255 iv for LD and oral for MD
    For Treatment B, participants will be administered with 0.05 mg/kg CG-0255 Besylate for IV infusion within 30 minutes on Day 1. Subsequently, they will receive 0.75 mg CG-0255 Besylate capsules once daily from Days 2 to 7.
  • Active Comparator: Treatment C: Plavix® 300mg for LD and 75mg for MD
    For Treatment C, participants will be administered with 300 mg Plavix® on Day 1 as 4 x 75 mg Plavix® tablets. Subsequently, they will receive 75 mg Plavix® once daily from Days 2 to 7.
  • Active Comparator: Treatment D: Plavix® 600mg for LD and 75mg for MD
    For Treatment D, participants will be administered with 600 mg Plavix® on Day 1 as 8 x 75 mg Plavix® tablets. Subsequently, they will receive 75 mg Plavix® once daily from Days 2 to 7.

Primary Outcome Measure

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. [ Time Frame: Day 1 (LD) and Day 7 (MD) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Syneos HealthMiamiFlorida33101
Isabel Pino
[email protected]
305-547-5813

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By research site
Syneos Health· Miami, FL

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