Status:

RECRUITING

A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.

Lead Sponsor:

Shanghai Synvida Biotechnology Co.,Ltd.

Conditions:

Healthy Participants

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.

Eligibility Criteria

Inclusion Criteria:

  1. Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg/m², 18.5 ≤ Caucasian participants ≤ 32 kg/m²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg;
  2. Healthy status: No evidence of active or chronic diseases in participants;
  3. Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.

Exclusion Criteria:

  1. Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;
  2. Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study;
  3. Subjects with designated examination results reaching a specified value;
  4. Subjects with abnormal laboratory test results deemed clinically significant by the investigator;
  5. Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody;
  6. Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1;
  7. Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1;
  8. Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening;
  9. Subjects who have donated blood or lost blood ≥ 400 mL within 3 months prior to drug administration, or donated blood or lost blood ≥ 200 mL within 1 month, or with a history of blood product use;
  10. Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients;
  11. Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration;
  12. Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding;
  13. Chinese female subjects who are postmenopausal or have an irregular menstrual cycle;
  14. Female subjects of childbearing potential, or male subjects whose female partners are of childbearing potential, who refuse to adopt reliable contraceptive measures during the study and for 6 months after the last drug administration;
  15. Any other factors that the investigator deems may render a subject unsuitable for study participation.

Key Trial Info

Start Date :

April 4 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT07469085

Start Date

April 4 2026

End Date

March 31 2027

Last Update

April 8 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Shanghai Xuhui Central Hospital

Shanghai, China, 200237

A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants. | DecenTrialz