PainPhase 1NCT06619392
A Single Dose Escalation Trial of HRS-2129 in Healthy Subjects
A Phase 1 study testing HRS-2129 in people with Pain, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics in healthy subjects, and to evaluate the food effect on pharmacokinetics of HRS-2129. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- HRS-2129
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2024to 20 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years old (inclusive);
- Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19.0 ~ 28.0 kg/m2 (inclusive);
- Subject has no plan to give a birth, donate sperm or eggs from signing the informed consent form to 6 months after last dose;
- Female subjects: non-pregnant or non-lactating;
- The skin to receive pain stimuli has no wound or derma disease.
- Subject who is willing to accept cold pain test.
- Subject who voluntarily signs the informed consent.
Who cannot join
- Subject who suffers from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities;
- Subject with the following abnormalities: aspartate aminotransferase, alanine aminotransferase, total bilirubin, or serum creatine value exceeds the upper limit of the normal range, QTcF > 450 ms, hyperpotassemia or hypopotassemia;
- Subject with a history of torsade de pointes, symptomatic ventricular arrhythmia, or personal or family history of short QT syndrome or long QT syndrome;
- Subject with a history of allergies to the IMP or its excipients, or subject with allergic constitution;
- Subject who underwent major surgery within 6 months prior to screening, or received surgery that may significantly affect the pharmacokinetics or safety evaluation of the IMP, or who plans to undergo surgery during the study period;
- Subject with a medication history that inhibits or induces liver metabolism of drug has been used within 1 month before administration;
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- Subject with vaccinated within 1 month prior to screening or plan to be vaccinated during the study;
- Subject who used any drugs or health products (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before administration, or who plans to receive other drug treatments during the study;
- Subject who has participated in clinical trials and received experimental drugs within 3 months before screening, or plans to participate in other clinical trials during this study;
- Donate blood/blood loss ≥ 400 mL within 3 months before screening;
- Subject who smoked more than 5 cigarettes per day on average within 3 months before screening;
- Drink more than 14 units of alcohol per week on average;
- Drink excessive tea, coffee or caffeinated beverages within 3 months before screening;
- Consume special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine and other food or drink) within 48 hours before administration;
- Subject who has special requirements for diet and cannot follow a unified diet;
- Subject with clinical significant abnormalities in medical examination;
- Subject with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis or human immunodeficiency virus antibody;
- Subject with a history of drug abuse or with a positive result for drug abuse test;
- Alcohol test result is positive;
- Subject who has difficulty in swallowing, or venous blood collection, or who cannot tolerate venipuncture, or who has a history of fainting of needle or blood;
- Subject may not be able to complete the study due to other reasons or the investigators considers that he is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of HRS-2129 and the Food Effect on Pharmacokinetics Following Single Dose Administration in Healthy Subjects
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics in healthy subjects, and to evaluate the food effect on pharmacokinetics of HRS-2129.
- Conditions
- Pain
- Being tested
- HRS-2129, HRS-2129 Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2129Drug
HRS-2129
HRS-2129 PlaceboDrug
HRS-2129 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment at dose level 1 | Experimental | Not described Receives: Drug: HRS-2129; Drug: HRS-2129 Placebo |
| Treatment at dose level 2 | Experimental | Not described Receives: Drug: HRS-2129; Drug: HRS-2129 Placebo |
| Treatment at dose level 3 | Experimental | Not described Receives: Drug: HRS-2129; Drug: HRS-2129 Placebo |
| Treatment at dose level 4 | Experimental | Not described Receives: Drug: HRS-2129; Drug: HRS-2129 Placebo |
| Treatment at dose level 5 | Experimental | Not described Receives: Drug: HRS-2129; Drug: HRS-2129 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: from ICF signing date to day 28 since last dose
Secondary outcomes (10)
Pharmacokinetic parameter of HRS-2129: Cmax
Measured: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: AUC0-t
Measured: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: AUC0-inf
Measured: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: Tmax
Measured: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: t1/2
Measured: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: CL/F
Measured: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: Vz/F
Measured: 0 hour to 216 hour after administration
Electrocardiogram measurement: QTcF interval
Measured: 90 minute predose to 48 hour after administration
Pain detection threshold for the Thermode Cold Test
Measured: 0 hour to 12 hour after administration
Pain tolerance time for the Thermode Cold Test
Measured: 0 hour to 12 hour after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start17 Oct 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS-2129 for dose escalation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619392
- Sponsor's protocol ID
- HRS-2129-101
- Status last verified
- Mar 2025
- First submitted
- 23 Sep 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang J, Wu Q, Wang S, Xie J, Deng K, Yang S, Yang X, Chen C, Yang G. First-in-Human Phase I Trial of HRS-2129, a Selective Nav1.8 Inhibitor: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects. Drug Des Devel Ther. 2026 Sep 3;20:628095. doi: 10.2147/DDDT.S628095. eCollection 2026.
PubMed 42712963
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of HRS-2129 and the Food Effect on Pharmacokinetics Following Single Dose Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06619392
- Acronym / sponsor ID
- HRS-2129-101
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 1 Oct 2024 (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.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics in healthy subjects, and to evaluate the food effect on pharmacokinetics of HRS-2129.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- HRS-2129 for dose escalation
| Arm | Type | Receives |
|---|---|---|
| Treatment at dose level 1 | Experimental | Drug: HRS-2129, Drug: HRS-2129 Placebo |
| Treatment at dose level 2 | Experimental | Drug: HRS-2129, Drug: HRS-2129 Placebo |
| Treatment at dose level 3 | Experimental | Drug: HRS-2129, Drug: HRS-2129 Placebo |
| Treatment at dose level 4 | Experimental | Drug: HRS-2129, Drug: HRS-2129 Placebo |
| Treatment at dose level 5 | Experimental | Drug: HRS-2129, Drug: HRS-2129 Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18 to 55 years old (inclusive);
- Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19.0 ~ 28.0 kg/m2 (inclusive);
- Subject has no plan to give a birth, donate sperm or eggs from signing the informed consent form to 6 months after last dose;
- Female subjects: non-pregnant or non-lactating;
- The skin to receive pain stimuli has no wound or derma disease.
Key exclusion criteria (21 listed)
- Subject who suffers from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities;
- Subject with the following abnormalities: aspartate aminotransferase, alanine aminotransferase, total bilirubin, or serum creatine value exceeds the upper limit of the normal range, QTcF > 450 ms, hyperpotassemia or hypopotassemia;
- Subject with a history of torsade de pointes, symptomatic ventricular arrhythmia, or personal or family history of short QT syndrome or long QT syndrome;
- Subject with a history of allergies to the IMP or its excipients, or subject with allergic constitution;
- Subject who underwent major surgery within 6 months prior to screening, or received surgery that may significantly affect the pharmacokinetics or safety evaluation of the IMP, or who plans to undergo surgery during the study period;
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 |
|---|---|---|
| HRS-2129HRS-2129 | Drug | Treatment at dose level 1, Treatment at dose level 2, Treatment at dose level 3, Treatment at dose level 4, Treatment at dose level 5 |
| HRS-2129 PlaceboHRS-2129 Placebo | Drug | Treatment at dose level 1, Treatment at dose level 2, Treatment at dose level 3, Treatment at dose level 4, Treatment at dose level 5 |
Primary outcome
The incidence and severity of adverse events
Time frame: from ICF signing date to day 28 since last dose
10 secondary outcomes
Pharmacokinetic parameter of HRS-2129: Cmax
Time frame: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: AUC0-t
Time frame: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: AUC0-inf
Time frame: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: Tmax
Time frame: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: t1/2
Time frame: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: CL/F
Time frame: 0 hour to 216 hour after administration
Pharmacokinetic parameter of HRS-2129: Vz/F
Time frame: 0 hour to 216 hour after administration
Electrocardiogram measurement: QTcF interval
Time frame: 90 minute predose to 48 hour after administration
Pain detection threshold for the Thermode Cold Test
Time frame: 0 hour to 12 hour after administration
Pain tolerance time for the Thermode Cold Test
Time frame: 0 hour to 12 hour after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 42712963Huang J, Wu Q, Wang S, Xie J, Deng K, Yang S, Yang X, Chen C, Yang G. First-in-Human Phase I Trial of HRS-2129, a Selective Nav1.8 Inhibitor: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects. Drug Des Devel Ther. 2026 Sep 3;20:628095. doi: 10.2147/DDDT.S628095. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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 HRS-2129 in people with Pain, run by Shandong Suncadia Medicine Co., Ltd. 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 5 Mar 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence and severity of adverse events (time frame: from ICF signing date to day 28 since last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06619392, which also lists 1 linked publication.
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 5 Mar 2025.