Evaluating the safety and tolerability of SV001 in healthy Chinese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to assess the safety, tolerability, pharmacokinetics, and immunogenicity of the investigational drug SV001 compared to a placebo in healthy adult volunteers from China. Participants will be closely monitored for any adverse reactions and overall health during the trial. The study is designed to gather essential data that will inform future research and potential therapeutic applications for conditions like idiopathic pulmonary fibrosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Xuhui District Central Hospital
  Shanghai, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New IPF drug ORJ-001 tested in adults with IPF

  A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

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• Nalbuphine ER for IPF-related chronic cough

  This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

  Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

• Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

  This observational study tests how fast patients with IPF or PPF can inhale through dry powder inhalers with different resistances.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07820254

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Rentosertib by mouth for people with idiopathic pulmonary fibrosis

  This is a randomized, placebo-controlled test to see if Rentosertib helps adults with idiopathic pulmonary fibrosis when taken as a pill.

  Recruiting at 12 sites Phase 3 InSilico Medicine Hong Kong Limited · Hefei, Anhui and 46 other locations · NCT07687459

• Inhaled nintedanib powder for IPF in adults

  This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

  Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.