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

A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: SV003; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qian Chen; Phone Number: 86-021-36682212; Email: xhzxyy@xh.sh.cn

Study Locations

• China
  • Shanghai, China, 200237
    • Recruiting
    • Shanghai Xuhui Central Hospital
    • Contact: Qian Chen; Phone Number: 86-021-36682212; Email: xhzxyy@xh.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo ： Single-dose
Experimental: SV003	Drug: SV003; SV003：Single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Adverse event type, incidence, duration	Approximately 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	PK (Pharmacokinetics)	Approximately 3 months
Peak time（Tmax）	PK (Pharmacokinetics)	Approximately 3 months
Area under the plasma concentration versus time curve (AUC)	PK (Pharmacokinetics)	Approximately 3 months
half-life（T1/2）	PK (Pharmacokinetics)	Approximately 3 months
Immunogenicity	ADA（Anti-drug antibody）	Approximately 3 months

Collaborators and Investigators

• Sponsor: Shanghai Synvida Biotechnology Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SV003-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No