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Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV261 Tablets

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorVigonvita Life Sciences

About this trial

This is a randomized, double-blind, placebo-controlled, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 45 years old, males or females;

Males weight no less than 50 kg, females weight no less than 45 kg, with body mass index of 19 to 26 kg/m²;

Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT and B-ultrasound of liver, gallbladder, pancreas, spleen, kidney and thyroid results 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 previous surgery that may significantly affect the body's metabolic process or safety evaluation of the study drug (such as liver, gallbladder, kidney, splenectomy, gastrointestinal resection or excessive blood loss that affects drug absorption, distribution, metabolism)

Participants with a history of diseases affecting bone marrow hematopoietic function or reducing immunological function (including leukemia, myelodysplastic syndrome, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis, etc.) or treatment history (tumor chemotherapy or radiotherapy, use of immunosuppressants, etc.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • VV261 600mg TID group

    Drug

    6 participants receive VV261 100mg 6 tablets,three times daily,orally; 2 participants will receive placebo,orally

  • VV261 900mg TID group

    Drug

    6 participants receive VV261 100mg 9 tablets,three times daily,orally; 2 participants will receive placebo,orally

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: VV261Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Cmax

Maximum observed plasma concentration

Time frame
Baseline to 72 hours after the last administration
2

Tmax

Time at which Cmax occurs

Time frame
Baseline to 72 hours after the last administration
3

Ctrough

Minimum observed steady-state plasma concentration

Time frame
Baseline to 72 hours after the last administration
4

AUC0-t

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

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

This trial is not recruiting at the moment. You can still explore other options: