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

NCT07469085 | Recruiting Phase 1

• 1 other identifier: SV003-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Adverse event type, incidence, duration

  Approximately 3 months

Secondary Outcomes (5)

• Peak Plasma Concentration (Cmax)

  Approximately 3 months

• Peak time（Tmax）

  Approximately 3 months

• Area under the plasma concentration versus time curve (AUC)

  Approximately 3 months

• half-life（T1/2）

  Approximately 3 months

• Immunogenicity

  Approximately 3 months

Study Arms (2)

SV003

EXPERIMENTAL

Drug: SV003

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SV003 DRUG

SV003：Single-dose

SV003

Placebo DRUG

Placebo ： Single-dose

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Healthy status: No evidence of active or chronic diseases in participants;
• Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.

You may not qualify if:

• Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;
• 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;
• Subjects with designated examination results reaching a specified value;
• Subjects with abnormal laboratory test results deemed clinically significant by the investigator;
• Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody;
• Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1;
• Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1;
• Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening;
• 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;
• Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients;
• Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration;
• Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding;
• Chinese female subjects who are postmenopausal or have an irregular menstrual cycle;
• 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;
• Any other factors that the investigator deems may render a subject unsuitable for study participation.

Sponsors & Collaborators

• Shanghai Synvida Biotechnology Co.,Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, 200237, China

RECRUITING

Central Study Contacts

Qian Chen

CONTACT

86-021-36682212; xhzxyy@xh.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: April 4, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

CN (1)