Study of the Safety, Tolerability, Pharmacokinetics of VV913 Capsules in Chinese Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorVigonvita Life Sciences

About this trial

This is a randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV913 Capsules in healthy adults.

Eligibility criteria

Qualifiers

Aged 18 to 45 years old, males ;

Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m²;

Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT are normal or considered abnormal without clinical significance by the investigator;

Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;

Disqualifiers

Participants with hypersensitivity to preparation or any of the excipients;

Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;

Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials; Participants with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);

Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;

Trial design

Treatments tested in this trial

  • VV913 1mg group
  • VV913 2mg group
  • VV913 4mg group
  • VV913 8mg group
  • VV913 15mg group
  • VV913 25mg group
  • VV913 40mg group

Treatment groups

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators