Health TrialsbyHealthPanel

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

ConditionHealthy Volunteers
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

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 ,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

Design model

Parallel

Treatments tested in this trial

  • VV913 1mg group

    Drug

    6 participants will receive VV913 1mg orally; 2 participants will receive placebo orally.

  • VV913 2mg group

    Drug

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

  • 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.

  • VV913 25mg group

    Drug

    6 participants will receive VV913 25mg orally; 2 participants will receive placebo orally.

  • VV913 40mg group

    Drug

    6 participants will receive VV913 40mg orally; 2 participants will receive placebo orally.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: VV913Experimental treatment 7 interventions
Group B: PlaceboPlacebo comparator 7 interventions

Trial outcomes

Primary outcomes

1

Cmax

maximum observed plasma concentration

Time frame
72 hours after administration
2

Tmax

time at which Cmax occurs

Time frame
72 hours after administration
3

t1/2

half life of elimination

Time frame
72 hours after administration
4

AUC0-t

area under the plasma concentration time curve from time zero to the last measurable concentration

Time frame
72 hours after 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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