Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorVigonvita Life Sciences
About this trial
This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） of multiple doses of VV913 in Chinese healthy adult participants.
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 ,Chest X-ray 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 4mg group
- VV913 8mg group
- VV913 15mg group
Treatment groups
24 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov