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Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules

ConditionHealthy Volunteers
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • VV913 4mg group

    Drug

    6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.

  • VV913 8mg group

    Drug

    6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.

  • VV913 15mg group

    Drug

    6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: VV913Experimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Incidence of Treatment-Emergent Adverse Events

Time frame
Baseline to 6 days after the last administration
2

Cmax

maximum observed plasma concentration

Time frame
Baseline to 72 hours after the last administration
3

AUC0-∞

area under the plasma concentration time curve from time zero to infinity

Time frame
Baseline to 72 hours after the last administration
4

Tmax

time at which Cmax occurs

Time frame
Baseline to 72 hours after the last administration

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vigonvita Life Sciences

Lead sponsor

Source ClinicalTrials.gov
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