Safety, Tolerability, and Pharmacokinetics of Multiple-Dose RFUS-949 in Healthy Chinese Participants

NCT07676357 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: RF-949-102
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute and Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs).

  Safety and tolerability will be assessed by monitoring the incidence and severity of AEs/SAEs, physical examinations, clinical laboratory tests (hematology, blood biochemistry, coagulation, urinalysis), vital signs, and 12-lead ECGs.

  From screening (Day -14) up to telephone follow-up at Day 13 (±1).

• Maximum plasma concentration (Cmax) of RFUS-949.

  Cmax will be evaluated after the first dose, and steady-state Cmax (Cmax,ss) will be evaluated after the last dose.

  Up to Day 9 (72 hours after the last dose on Day 6).

• Area under the plasma concentration-time curve (AUC) of RFUS-949.

  AUC from time zero to the last quantifiable concentration (AUC0-t) will be evaluated after the first dose, and steady-state AUC within the dosing interval (AUC0-tau,ss) will be evaluated after the last dose.

  Up to Day 9 (72 hours after the last dose on Day 6).

Study Arms (5)

RFUS-949 100 mg QD

EXPERIMENTAL

Participants receive RFUS-949 100 mg tablets orally once daily (QD) for 6 consecutive days

Drug: RFUS-949

RFUS-949 150 mg BID

EXPERIMENTAL

Participants receive RFUS-949 150 mg tablets orally twice daily (BID) for 6 consecutive days (single dose on Day 6).

Drug: RFUS-949

RFUS-949 300 mg BID

EXPERIMENTAL

Participants receive RFUS-949 300 mg tablets orally twice daily (BID) for 6 consecutive days (single dose on Day 6).

Drug: RFUS-949

RFUS-949 400 mg BID

EXPERIMENTAL

Participants receive RFUS-949 400 mg tablets orally twice daily (BID) for 6 consecutive days (single dose on Day 6).

Drug: RFUS-949

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo tablets orally once daily (QD) or twice daily (BID) for 6 consecutive days.

Drug: Placebo

Interventions

RFUS-949 DRUG

RFUS-949 is formulated as an oral tablet, available in 50 mg and 200 mg strengths.

RFUS-949 100 mg QD; RFUS-949 150 mg BID; RFUS-949 300 mg BID; RFUS-949 400 mg BID

Placebo DRUG

Matching placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 (HIV) antibody at screening.
• Use of any prescription drugs, over-the-counter (OTC) drugs, herbal medicines, vitamins, or dietary supplements within 14 days or 5 half-lives of the drug/active metabolite (whichever is longer) prior to randomization.
• Use of any drugs that inhibit or induce hepatic drug metabolism within 30 days prior to randomization (e.g., inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, statins).
• Consumption of dragon fruit, mango, grapefruit, starfruit, or foods/drinks prepared from them, or foods/drinks containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets affecting drug absorption, distribution, metabolism, or excretion within 48 hours prior to randomization, or inability to stop such diet during the study.
• Average daily consumption of excessive tea, coffee, and/or caffeinated beverages (\> 8 cups/day, 1 cup ≈ 250 mL) within 3 months prior to randomization, or inability to abstain during the study.
• Special dietary requirements or inability to accept the standardized diet during the study.
• Intolerance to venipuncture, or history of needle phobia or blood phobia.
• Smoking more than 5 cigarettes per day within 3 months prior to randomization, or inability to stop using any tobacco products during the study.
• Average weekly alcohol consumption \> 14 units (1 unit ≈ 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine) within 3 months prior to randomization, inability to abstain from alcohol during the study, or a positive alcohol breath test.
• History of drug abuse within 6 months prior to randomization, positive result in any drug abuse screen, or history of drug addiction/long-term drug use.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Yichang Humanwell Pharmaceutical Co., Ltd., China: collaborator

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: January 22, 2026
• Primary Completion: June 28, 2026
• Study Completion: August 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)