Safety, tolerability and blood-level testing of SV003 in healthy adults.

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.

This trial tests whether SV003 is safe, well tolerated, and how it behaves in the body in healthy adults compared with placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Synvida Biotechnology Co.,Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07469085 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional trial in healthy adult volunteers to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SV003 versus placebo. Participating adults who meet BMI and weight criteria will receive SV003 or placebo under controlled conditions with medical monitoring. The protocol includes serial blood sampling and clinical assessments to measure drug levels and biological effects and to capture adverse events. Results will inform dosing and safety for later patient studies.

Who should consider this trial

Good fit: Healthy adults who meet the trial's BMI and minimum weight requirements, have no active or chronic disease, can give informed consent, and meet screening lab criteria are eligible.

Not a fit: People with active or chronic illnesses, clinically significant abnormal lab results, recent serious illness, or positive viral hepatitis markers would be excluded and are unlikely to benefit from this Phase 1 testing.

Why it matters

Potential benefit: If SV003 is shown to have an acceptable safety and PK/PD profile in healthy people, it could enable further testing in patients with target conditions.

How similar studies have performed: Phase 1 PK/PD testing in healthy volunteers is a standard early step that often establishes a safety profile before patient trials, but no prior public data for SV003 are provided here.

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.

Where this trial is running

Shanghai

• Shanghai Xuhui Central Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Qian Chen

Conditions Healthy Participants