A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: SV001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Xuhui District Central Hospital
    • Contact: Qian Chen; Phone Number: 0086-021-54036058; Email: qchen@shxh-centerlab.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;
2. Subjects must have a Body Mass Index in the range of 19~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;
3. Subjects must be in good health as judged by the investigator.
4. Reliable contraception must be assured during and for some time after the trial.

Exclusion Criteria:

1. Subjects with a history of drug or other substance anaphylaxis;
2. Subjects with respiratory symptoms or abnormal respiratory tract;
3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
4. Subjects with other diseases or factors with abnormal clinical manifestations;
5. Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;
6. Subjects who smoked more than 5 cigarettes a day in the period before screening;
7. Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;
8. Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;
9. Subjects who used other drugs within a certain period of time before receiving the investigational drug;
10. Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;
11. Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.
12. Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;
13. Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;
14. Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;
15. Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;
16. Any other status in which the investigator deems inappropriate to participate in the present study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo ： single-dose
Experimental: SV001	Drug: SV001; SV001 ： 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 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	PK (Pharmacokinetics)	Approximately 1 years
Peak time（Tmax）	PK (Pharmacokinetics)	Approximately 1 years
Area under the plasma concentration versus time curve (AUC)	PK (Pharmacokinetics)	Approximately 1 years
half-life（T1/2）	PK (Pharmacokinetics)	Approximately 1 years
Immunogenicity	ADA（Anti-drug antibody）	Approximately 1 years

Collaborators and Investigators

• Sponsor: Shanghai Synvida Biotechnology Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: SV001-101

Drug and device information, study documents

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