Recruiting NCT07469085
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SV003, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
Interventions
- Drug SV003
SV003：Single-dose - Drug Placebo
Placebo ： Single-dose
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events [Time frame: Approximately 3 months]
Secondary outcome measures (5)
- Peak Plasma Concentration (Cmax) [Time frame: Approximately 3 months]
- Peak time（Tmax） [Time frame: Approximately 3 months]
- Area under the plasma concentration versus time curve (AUC) [Time frame: Approximately 3 months]
- half-life（T1/2） [Time frame: Approximately 3 months]
- Immunogenicity [Time frame: Approximately 3 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Xuhui Central Hospital — Shanghai
Identifiers
NCT: NCT07469085 · SV003-101