Acute and Chronic PainPhase 1NCT07676357
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose RFUS-949 in Healthy Chinese Participants
A Phase 1 study testing RFUS-949 in people with Acute and Chronic Pain, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute and Chronic Pain
- What is being tested?
- RFUS-949
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2026to 1 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Vaccinated within 1 month prior to randomization or plan to be vaccinated during the study.
- Blood donation or blood loss >= 200 mL, or receipt of blood transfusion/blood products within 3 months prior to randomization, or plan to donate blood or blood components during the study or within 3 months after the study ends.
- Female participants who are pregnant, lactating, or have a positive pregnancy test result at screening or during the study.
- Female participants who have used oral contraceptives within 30 days, or long-acting estrogen or progestin injections/implants within 6 months prior to study drug administration.
- Participation in another clinical trial and received study treatment within 3 months prior to randomization.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
About this study
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
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
- Being tested
- RFUS-949, Placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFUS-949Drug
RFUS-949 is formulated as an oral tablet, available in 50 mg and 200 mg strengths.
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| RFUS-949 100 mg QD | Experimental | Participants receive RFUS-949 100 mg tablets orally once daily (QD) for 6 consecutive days Receives: 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). Receives: 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). Receives: 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). Receives: Drug: RFUS-949 |
| Placebo | Placebo comparator | Participants receive matching placebo tablets orally once daily (QD) or twice daily (BID) for 6 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to Day 9 (72 hours after the last dose on Day 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start22 Jan 2026
- Primary completion28 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute and Chronic PainStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676357
- Sponsor's protocol ID
- RF-949-102
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07676357
- Acronym / sponsor ID
- RF-949-102
- Conditions
- Acute and Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RFUS-949 100 mg QD | Experimental | Drug: RFUS-949Participants receive RFUS-949 100 mg tablets orally once daily (QD) for 6 consecutive days |
| RFUS-949 150 mg BID | Experimental | Drug: RFUS-949Participants receive RFUS-949 150 mg tablets orally twice daily (BID) for 6 consecutive days (single dose on Day 6). |
| RFUS-949 300 mg BID | Experimental | Drug: RFUS-949Participants receive RFUS-949 300 mg tablets orally twice daily (BID) for 6 consecutive days (single dose on Day 6). |
| RFUS-949 400 mg BID | Experimental | Drug: RFUS-949Participants receive RFUS-949 400 mg tablets orally twice daily (BID) for 6 consecutive days (single dose on Day 6). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive matching placebo tablets orally once daily (QD) or twice daily (BID) for 6 consecutive days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFUS-949RFUS-949 is formulated as an oral tablet, available in 50 mg and 200 mg strengths. | Drug | RFUS-949 100 mg QD, RFUS-949 150 mg BID, RFUS-949 300 mg BID, RFUS-949 400 mg BID |
| PlaceboMatching placebo tablets | Drug | Placebo |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Time frame: From screening (Day -14) up to telephone follow-up at Day 13 (±1).
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.
Maximum plasma concentration (Cmax) of RFUS-949.
Time frame: Up to Day 9 (72 hours after the last dose on Day 6).
Cmax will be evaluated after the first dose, and steady-state Cmax (Cmax,ss) will be evaluated after the last dose.
Area under the plasma concentration-time curve (AUC) of RFUS-949.
Time frame: Up to Day 9 (72 hours after the last dose on Day 6).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RFUS-949 in people with Acute and Chronic Pain, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) and serious adverse events (SAEs). (time frame: From screening (Day -14) up to telephone follow-up at Day 13 (±1).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.