Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects

Last updated: February 13, 2025
Sponsor: Rezubio Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetic Foot Ulcers

Diabetic Vitreous Hemorrhage

Diabetic Neuropathy

Treatment

RZ-629

Placebo

Clinical Study ID

NCT06829563
RZ-629-EN-01
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A total of 50 healthy subjects will be allocated to 5 groups in the SAD study. Each group includes 10 subjects (8 subjects will receive RZ-629 and 2 receive placebo). All subjects will check-in on the day before the administration (Day -1) and on Day 1. Each subject in fasted state will be randomly assigned to receive a single oral dose of RZ-629 or placebo. Subjects will remain in the clinical research unit (CRU) through the completion of the safety/tolerability evaluation. The safety review committee (SRC) will review all safety data and blinded summary of available PK data through the safety follow-up and decide to proceed to the next dose level.

Eligibility Criteria

Inclusion

Inclusion Criteria: 1. Sign the informed consent form (ICF) before the study, and fully understand the content, process and possible adverse reactions of the trial.

  1. Healthy male or female subjects between the ages of 18 and 65 years, inclusive.

  2. With a minimum body weight of 50 kg for males, and 45 kg for females, have a BMI of 18 to 32 kg/m2, inclusive.

  3. Fasting plasma glucose is between 3.9 mmol/L (70.2 mg/dL) and 6.1 mmol/L (109.8mg/dL) at screening.

  4. In good health, with no clinically relevant acute or chronic medical conditions orsevere diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine,pulmonary, neurologic, psychiatric, respiratory, blood, immune or dermatologicalsystems, as judged by the investigator.

  5. With no clinically significant findings from vital signs measurements, physicalexamination, clinical laboratory evaluations and 12-lead ECG, as judged by theinvestigator.

  6. Subjects must be willing to understand and comply with all research procedures andrestrictions and be able to communicate effectively with researchers.

Exclusion

Exclusion Criteria: 1. With a specific history of allergies or known to have multiple allergies.

  1. Have experienced acute illnesses within 2 weeks prior to the first dose or aretaking concomitant medications.

  2. With a history or current presence of dysphagia or diseases that may potentiallyinterfere with drug absorption or metabolism.

  3. Subjects and their first-degree relatives with a history of diabetes beforescreening.

  4. With a history of hypoglycemia or with impaired awareness or cognition ofhypoglycemic symptoms within 3 months prior to screening.

  5. History of previous corrected QT interval (QTc) prolongation or clinically abnormalelectrocardiogram (ECG) finding during screening.

  6. Have undergone major surgery within the past 6 months, or those planning to undergosurgery during the study period.

  7. Have used any medications and dietary supplements within 2 weeks prior to the firstdose.

  8. Within 48 h prior to the first dose, have consumed food or beverages containingcaffeine, alcohol, or concentrated tea, or those who have consumed special dietsand/or purine-rich diets or have other factors that may affect drug absorption,distribution, metabolism, or excretion.

  9. Have received vaccinations within 4 weeks prior to the first dose or plan to receivevaccinations during the trial.

  10. Have participated in other clinical trials within 3 months prior to the first dose,or those planning to participate in other trials during the study period.

  11. Have donated blood and blood products (including plasma) within 3 months prior tothe first dose or have experienced non-physiological blood loss of ≥ 400 mL within 6months.

  12. Have consumed an average of more than 14 units of alcohol per week within the past 12 months prior to screening.

  13. Have smoked more than 5 cigarettes per day within the past 3 months or cannot stopusing any tobacco products during the study.

  14. With a history of drug abuse within the past 12 months or positive drug abuse atscreening.

  15. With positive results for serology of infectious diseases at screening. 17. Cannottolerate venipuncture/indwelling needle or have a history of vasovagal syncope.

  16. Subjects deemed unsuitable for participation in this trial by the investigator dueto other factors.

  17. With chronic or acute gastrointestinal inflammation. 20. Abnormal liver functiontests: ALT or AST > 2×ULN, or TBIL > 1.5×ULN. 21. Use of drugs that may affectglucose metabolism (e.g., systemic steroids, nonselective β-blockers, monoamineoxidase inhibitors) within 1 month prior to screening.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: RZ-629
Phase: 1
Study Start date:
January 30, 2025
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • CMAX

    Adelaide,
    Australia

    Active - Recruiting

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