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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06267183
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Synvida Biotechnology Co.,Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: SV001

Placebo Comparator: Placebo

Interventions

Drug: - SV001

SV001 : single-dose

Drug: - Placebo

Placebo : single-dose

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai Xuhui District Central Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Xuhui District Central Hospital

Shanghai, ,

Site Contact

Qian Chen

[email protected]

0086-021-54036058