Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV261 Tablets (NCT07710326) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV261 Tablets
China16 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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/m\^2;
. 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;
. Participants who are able to understand and follow the study protocol and instructions; participants who have voluntarily decided to participate in this study, and sign the informed consent form.
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax
Timeframe: Baseline to 72 hours after the last administration
2
Tmax
Timeframe: Baseline to 72 hours after the last administration
3
Ctrough
Timeframe: Baseline to 72 hours after the last administration
4
AUC0-t
Timeframe: Baseline to 72 hours after the last administration
5
AUC0-∞
Timeframe: Baseline to 72 hours after the last administration
6
t1/2
Timeframe: Baseline to 72 hours after the last administration
7
CL/F
Timeframe: Baseline to 72 hours after the last administration
. 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.);
. Participants with a history of spleen diseases;
. If any of the following parameters were considered abnormal with clinical significance: white blood cell count, red blood cell count, platelet count, reticulocyte count, and absolute neutrophil count;
. If any of the following parameters were considered abnormal with clinical significance: total bilirubin, alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase;
. Participants who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (excluding menstruation);
Timeframe: Baseline to 72 hours after the last administration
9
Vd/F
Timeframe: Baseline to 72 hours after the last administration
10
Incidence of Treatment-Emergent Adverse Events
Timeframe: Baseline to 7days after the last administration