Safety, Tolerability, and Pharmacokinetics of Multiple-Dose RFUS-949 in Healthy Chinese Participants
Active, not recruitingPhase 1NCT07676357
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial. The primary objective is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RFUS-949 tablets following multiple oral doses in healthy Chinese adult participants (aged 18 to 45 years). The study is designed to explore the multiple-dose characteristics of the investigational drug. It consists of a once-daily (QD) dosing cohort and three twice-daily (BID) dose escalation cohorts. Participants will receive multiple oral doses of either RFUS-949 or a matching placebo in a fasting state for 6 consecutive days, with rigorous safety monitoring and PK blood sampling throughout the study period.
Study details
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of RFUS-949 Tablets in Healthy Chinese Participants
- Conditions
- Acute and Chronic Pain
- Interventions
- Drug: RFUS-949
- Drug: Placebo
- Sponsor
- The Affiliated Hospital of Qingdao University
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Start date
- 2026-01-22
- Primary completion
- 2026-06-28
- Sex
- All
- Age range
- from 18 Years to 45 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Signed informed consent form (ICF) prior to the study, fully understands the study content, procedures, and possible adverse reactions; willing to participate and able to complete the study according to the protocol requirements. * Male or female, aged 18 to 45 years (inclusive). * Body weight \>= 50.0 kg for males and \>= 45.0 kg for females, with Body Mass Index (BMI) between 19.0 and 28.0 kg/m\^2 (inclusive). * Female participants and their partners are willing to have no pregnancy plans and use effective contraception methods from 2 weeks prior to screening up to 6 months after the last dose; male participants and their partners are willing to have no pregnancy plans and use effective contraception methods from signing the ICF up to 6 months after the last dose. No sperm or egg donation plans during this period. Exclusion Criteria: * Known allergy to the active ingredient or excipients of the study drug, history of specific allergies (e.g., asthma, urticaria, eczema), or highly allergic constitution (e.g., allergic to two or more drugs/foods, highly sensitive to environmental substances). * History or presence of clinically significant diseases requiring exclusion as judged by the investigator, including but not limited to neurological/psychiatric, respiratory, cardiovascular, hematological/lymphatic, urinary, endocrine, immune system diseases, and metabolic abnormalities. * History of dysphagia or gastrointestinal diseases, especially those affecting drug absorption (e.g., gastric or small bowel resection, gastric or duodenal ulcers, atrophic gastritis, gastrointestinal bleeding, obstruction, cholecystitis, gallstones), or chronic constipation/diarrhea. * Received surgical operation within 3 months prior to randomization, planned surgery during the study, or previous surgery that may affect drug absorption, distribution, metabolism, or excretion. * Clinically significant abnormal findings in physical examination, vital signs, or laboratory tests at screening, which in the opinion of the investigator make the participant unsuitable for the study. \* History or presence of prolonged QTc interval, or screening QTcF \> 450 ms (females) or QTcF \> 430 ms (males) (Fridericia's formula: QTc = QT/RR\^0.33), or clinically significant abnormal ECG results at screening. * Positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Treponema pallidum (syphilis) antibody, or Human Immunodeficiency Virus (H…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07676357