JKN2306 in Healthy Subjects: Single Ascending Dose and Food Effect Study

NCT07412938 | Completed Phase 1

• 1 other identifier: JKN2306-I
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.

Secondary Outcomes (9)

• Pharmacokinetic parameter of JKN2306: Tmax

  SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.

• Pharmacokinetic parameter of JKN2306: Cmax

  SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.

• Pharmacokinetic parameter of JKN2306: T1/2

  SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.

• Pharmacokinetic parameter of JKN2306: AUC0-last

  SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.

• Pharmacokinetic parameter of JKN2306: AUC0-inf

  SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.

Study Arms (5)

JKN2306 10 mg (SAD)

EXPERIMENTAL

JKN2306 10mg only, without placebo.

Drug: JKN2306

JKN2306 30 mg (SAD)

EXPERIMENTAL

JKN2306 30 mg

Drug: JKN2306; Drug: Placebo

JKN2306 100 mg (SAD)

EXPERIMENTAL

JKN2306 100 mg

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.

Drug: JKN2306; Drug: Placebo

JKN2306 400 mg (SAD)

EXPERIMENTAL

JKN2306 400 mg

Drug: JKN2306; Drug: Placebo

Interventions

JKN2306 DRUG

JKN2306 tablet, oral

JKN2306 10 mg (SAD); JKN2306 100 mg (SAD); JKN2306 200 mg (SAD + FE subset); JKN2306 30 mg (SAD); JKN2306 400 mg (SAD)

Placebo DRUG

matching placebo tablet

JKN2306 100 mg (SAD); JKN2306 200 mg (SAD + FE subset); JKN2306 30 mg (SAD); JKN2306 400 mg (SAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Joincare Pharmaceutical Group Industry Co., Ltd: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 214000, China

Location

MeSH Terms

Conditions

Acute 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 17, 2026
• Study Start: February 12, 2025
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: February 17, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)