Acute PainPhase 1NCT07412938
JKN2306 in Healthy Subjects: Single Ascending Dose and Food Effect Study
A Phase 1 study testing JKN2306 in people with Acute Pain, run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
Trial summary
This first-in-human, single-center study in China evaluated the safety, tolerability, and pharmacokinetics of single oral doses of JKN2306 tablets in healthy adult subjects and assessed the effect of a high-fat, high-calorie meal on the pharmacokinetics of JKN2306. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- JKN2306
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2025to 2 Jul 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
- Healthy Chinese males or females aged 18 to 55 years (inclusive).
- Body weight ≥50 kg for males and ≥45 kg for females; BMI 19.0 to 28.0 kg/m² (inclusive).
- Able and willing to comply with study procedures and restrictions and to complete the study as planned.
- Willing to use medically acceptable contraception and have no plan for pregnancy, sperm donation, or oocyte donation from signing informed consent through 90 days after the last dose.
Who cannot join
- Participation in another clinical trial within 3 months prior to screening or planned participation during the study.
- Clinically significant diseases or abnormalities that may affect safety or study participation; or conditions that may interfere with absorption, distribution, metabolism, or excretion (e.g., relevant gastrointestinal disorders).
- History of photosensitivity or hypersensitivity/allergy to study drug components, other drugs, or foods.
- Serious infection/major trauma/major surgery within 3 months prior to dosing, or planned surgery during the study; febrile illness or evidence of active infection within 2 weeks prior to first dose.
- Use of medications that may affect hepatic drug metabolism within 28 days; use of prescription/OTC drugs, herbal products, vitamins, or supplements within 14 days prior to dosing or planned use during the study.
- Consumption of grapefruit-related products/caffeine/alcohol and other specified dietary restrictions within 48 hours prior to first dose or unwillingness to comply with dietary restrictions.
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- Drug abuse history or positive drug screen; excessive alcohol use or positive breath alcohol test; excessive nicotine use or positive cotinine screen.
- Clinically significant abnormalities in physical examination, vital signs, ECG, or laboratory tests (hematology/urinalysis/biochemistry/coagulation), imaging, or infectious disease screening; positive HBsAg, HCV Ab, syphilis Ab, or HIV Ag/Ab.
- Pregnant or lactating females, or positive pregnancy test.
- History of QTc prolongation or clinically significant ECG abnormalities; QTcF ≥450 ms (males) or ≥470 ms (females) confirmed on repeat measurement.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 214000
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single Oral Doses of JKN2306 Tablets in Healthy Subjects
This first-in-human, single-center study in China evaluated the safety, tolerability, and pharmacokinetics of single oral doses of JKN2306 tablets in healthy adult subjects and assessed the effect of a high-fat, high-calorie meal on the pharmacokinetics of JKN2306.
Read the detailed description
The study consisted of a single ascending dose (SAD) part and a food effect (FE) part. The SAD part was a single-center, randomized, double-blind, placebo-controlled study with five dose cohorts (10 mg, 30 mg, 100 mg, 200 mg, and 400 mg). The FE assessment was conducted sequentially in subjects participating in the 200 mg cohort using two dosing periods separated by a washout; dosing was performed under fasting conditions in Period 1 and under fed conditions (high-fat, high-calorie meal) in Period 2. Pharmacokinetic sampling and safety assessments were performed per protocol, and exploratory assessments included concentration-QTc analysis and metabolite profiling.
- Conditions
- Acute Pain
- Being tested
- JKN2306, Placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKN2306Drug
JKN2306 tablet, oral
PlaceboDrug
matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| JKN2306 10 mg (SAD) | Experimental | JKN2306 10mg only, without placebo. Receives: Drug: JKN2306 |
| JKN2306 30 mg (SAD) | Experimental | JKN2306 30 mg Receives: Drug: JKN2306; Drug: Placebo |
| JKN2306 100 mg (SAD) | Experimental | JKN2306 100 mg Receives: Drug: JKN2306; Drug: Placebo |
| JKN2306 200 mg (SAD + FE subset) | Experimental | Period 1 (fasted): single oral dose under fasting conditions. Period 2 (fed): after washout (planned 7 days), subjects consume a high-fat, high-calorie meal within 30 minutes and take the assigned study product 30 minutes after starting the meal. Receives: Drug: JKN2306; Drug: Placebo |
| JKN2306 400 mg (SAD) | Experimental | JKN2306 400 mg Receives: Drug: JKN2306; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single oral doses of JKN2306
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatmentemergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Secondary outcomes (9)
Pharmacokinetic parameter of JKN2306: Tmax
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: Cmax
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: T1/2
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: AUC0-last
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: AUC0-inf
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: CL/F
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: Vz/F
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: Kel
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: MRT
Measured: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Feb 2025
- Primary completion2 Jul 2025
- Study completion2 Jul 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 Acute PainStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412938
- Sponsor's protocol ID
- JKN2306-I
- Status last verified
- Aug 2025
- First submitted
- 26 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Han M, Cui G, Zhang D, Wu W, Mi N, Jin J, Zhang S, Zhang X, Li J, Xiao C, Wang J, Gou C, Su C, Li J. A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Highly Selective NaV1.8 Inhibitor JKN2306 in Healthy Chinese Subjects. Pharmacol Res Perspect. 2026 Jun;14(3):e70277. doi: 10.1002/prp2.70277.
PubMed 42290196
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single Oral Doses of JKN2306 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07412938
- Acronym / sponsor ID
- JKN2306-I
- Conditions
- Acute Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 17 Feb 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 first-in-human, single-center study in China evaluated the safety, tolerability, and pharmacokinetics of single oral doses of JKN2306 tablets in healthy adult subjects and assessed the effect of a high-fat, high-calorie meal on the pharmacokinetics of JKN2306.
Detailed description
The study consisted of a single ascending dose (SAD) part and a food effect (FE) part. The SAD part was a single-center, randomized, double-blind, placebo-controlled study with five dose cohorts (10 mg, 30 mg, 100 mg, 200 mg, and 400 mg). The FE assessment was conducted sequentially in subjects participating in the 200 mg cohort using two dosing periods separated by a washout; dosing was performed under fasting conditions in Period 1 and under fed conditions (high-fat, high-calorie meal) in Period 2. Pharmacokinetic sampling and safety assessments were performed per protocol, and exploratory assessments included concentration-QTc analysis and metabolite profiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| JKN2306 10 mg (SAD) | Experimental | Drug: JKN2306JKN2306 10mg only, without placebo. |
| JKN2306 30 mg (SAD) | Experimental | Drug: JKN2306, Drug: PlaceboJKN2306 30 mg |
| JKN2306 100 mg (SAD) | Experimental | Drug: JKN2306, Drug: PlaceboJKN2306 100 mg |
| JKN2306 200 mg (SAD + FE subset) | Experimental | Drug: JKN2306, Drug: PlaceboPeriod 1 (fasted): single oral dose under fasting conditions. Period 2 (fed): after washout (planned 7 days), subjects consume a high-fat, high-calorie meal within 30 minutes and take the assigned study product 30 minutes after starting the meal. |
| JKN2306 400 mg (SAD) | Experimental | Drug: JKN2306, Drug: PlaceboJKN2306 400 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Chinese males or females aged 18 to 55 years (inclusive).
- Body weight ≥50 kg for males and ≥45 kg for females; BMI 19.0 to 28.0 kg/m² (inclusive).
- Able and willing to comply with study procedures and restrictions and to complete the study as planned.
- Willing to use medically acceptable contraception and have no plan for pregnancy, sperm donation, or oocyte donation from signing informed consent through 90 days after the last dose.
Key exclusion criteria (10 listed)
- Participation in another clinical trial within 3 months prior to screening or planned participation during the study.
- Clinically significant diseases or abnormalities that may affect safety or study participation; or conditions that may interfere with absorption, distribution, metabolism, or excretion (e.g., relevant gastrointestinal disorders).
- History of photosensitivity or hypersensitivity/allergy to study drug components, other drugs, or foods.
- Serious infection/major trauma/major surgery within 3 months prior to dosing, or planned surgery during the study; febrile illness or evidence of active infection within 2 weeks prior to first dose.
- Use of medications that may affect hepatic drug metabolism within 28 days; use of prescription/OTC drugs, herbal products, vitamins, or supplements within 14 days prior to dosing or planned use during 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 |
|---|---|---|
| JKN2306JKN2306 tablet, oral | Drug | JKN2306 10 mg (SAD), JKN2306 100 mg (SAD), JKN2306 200 mg (SAD + FE subset), JKN2306 30 mg (SAD), JKN2306 400 mg (SAD) |
| Placebomatching placebo tablet | Drug | JKN2306 100 mg (SAD), JKN2306 200 mg (SAD + FE subset), JKN2306 30 mg (SAD), JKN2306 400 mg (SAD) |
Primary outcome
Safety and tolerability of single oral doses of JKN2306
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatmentemergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
9 secondary outcomes
Pharmacokinetic parameter of JKN2306: Tmax
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: Cmax
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: T1/2
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: AUC0-last
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: AUC0-inf
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: CL/F
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: Vz/F
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: Kel
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Pharmacokinetic parameter of JKN2306: MRT
Time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
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 17 Feb 2026.
- Derived from this study: PubMed 42290196Yang Y, Han M, Cui G, Zhang D, Wu W, Mi N, Jin J, Zhang S, Zhang X, Li J, Xiao C, Wang J, Gou C, Su C, Li J. A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Highly Selective NaV1.8 Inhibitor JKN2306 in Healthy Chinese Subjects. Pharmacol Res Perspect. 2026 Jun;14(3):e70277. doi: 10.1002/prp2.70277.
- Individual participant dataSharing planned: No
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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 JKN2306 in people with Acute Pain, run by Joincare Pharmaceutical Group Industry 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 4 inclusion and 10 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 17 Feb 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. 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?
Safety and tolerability of single oral doses of JKN2306 (time frame: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-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 NCT07412938, 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 17 Feb 2026.