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

Shanghai Synvida Biotechnology

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: SV003

Study type: Interventional

Funder types: Industry

Identifiers

NCT07469085

SV003-101

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

SV003

Experimental group

Treatment:

Drug: SV003

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo