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Not yet recruitingNCT07557537Updated Apr 29, 2026

A Phase 1 Study of KHN707 Tablets in Healthy Participants

A Phase 1 interventional study of KHN707 tablet and Placebo in Healthy Adult Participants, sponsored by Chengdu Kanghong Pharmaceutical Group Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a single-center, randomized, double-blind, placebo-controlled study . The objective is to evaluate the safety , tolerability and PK profile of KHN707 tablets in Chinese healthy participants.

Read the detailed description

This study will enroll approximately 38 participants across 5 dose cohorts. Participants will be administered with a single dose or two doses of KHN707 or its matching placebo under a fasting or fed state.

The safety and tolerability will be evaluated by monitoring and assessment of AEs, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation, etc.), physical examination findings, etc.

02

Conditions studied

  • Healthy Adult Participants
03

In context

Lead sponsor

Chengdu Kanghong Pharmaceutical Group Co., Ltd. is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 1.Age: 18 to 45 years old (inclusive), Male or female.
  • 2.Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19\~26 kg/m2 (inclusive).
  • 3. Effective contraception measures and no sperm/egg donation plan from signing the informed consent to 3 months after last dose.
  • 4.Fully understand the procedures and sigh the informed consent.

Exclusion criteria

Exclusion Criteria:

  • 1. Participants with clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, abdominal ultrasound , or chest X-ray as judged by the investigator during screening .
  • 2.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or bilirubin above the upper limit of normal, or creatinine (Cr) above the upper limit of normal at screening or baseline.
  • 3.Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody at ScreeningDysphagia or history of gastrointestinal diseases, liver and kidney diseases that can affect the pharmacokinetic behavior of drugs as judged by the investigator.
  • 4.Participants with medical history of clinically significant conditions that may affect the study per investigator assessment-including but not limited to disorders of the central nervous, cardiovascular, respiratory, digestive, urinary, endocrine, hematologic or immune systems; malignancies; metabolic disorders; any physiological conditions interfering with trial results; or psychiatric/cerebral dysfunction disorders based on investigator determination of unsuitability..
  • 5.Participants with dysphagia or a history of gastrointestinal diseases or liver/kidney diseases that, in the investigator's judgment, could affect the pharmacokinetic behavior of the drug.
  • 6. Participants who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study period, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion.
  • 7. Participants who are allergic to the investigational drug or any of its excipients, or have a history of two or more allergies to other drugs, foods, or environmental factors, or have a constitution prone to allergic symptoms such as rash or urticaria.
  • 8. Participants with cardiac diseases, including but not limited to congenital long QT syndrome, torsade de pointes, or risk factors for torsade de pointes (e.g., hypokalemia, family history of long QT syndrome), current use of Class IA (e.g., quinidine or procainamide) or Class III (e.g., amiodarone or sotalol) antiarrhythmic drugs or other drugs known to affect the QT interval, or a QTc interval corrected by Fridericia's formula (QTcF) >450 ms for males or >470 ms for females at screening, or other clinically significant abnormalities on 12-lead ECG.
  • 9. Participants who have taken insomnia-related medications or received insomnia-related treatment within 3 months prior to screening.
  • 10. Participants who have received vaccination within 30 days prior to screening.
  • 11. Participants who have used any drugs/products that affect drug absorption, metabolism, or elimination (e.g., barbiturates, carbamazepine, phenytoin, rifampin, itraconazole, ketoconazole, cimetidine, cyclosporine, macrolides, verapamil, quinolones, azole antifungals, HIV protease inhibitors, gemfibrozil, etc.) within 30 days prior to dosing.
  • 12. Participants who have used any medications or health products (including herbal medicines, vitamins) for any reason within 14 days prior to the first dose of the study drug.
  • 13. Participants with special dietary requirements who cannot comply with the provided diet and corresponding regulations.
  • 14. Participants who have consumed any beverages or foods containing alcohol or caffeine, or engaged in vigorous exercise, or had other factors affecting drug absorption, distribution, metabolism, or excretion within 48 hours prior to the first dose; or participants who do not agree to abstain from tea, coffee, and/or caffeinated beverages and foods during the study period.
  • 15. Participants who have donated blood or lost a significant amount of blood (>400 mL) within 3 months prior to screening.
  • 16. Participants who have participated in another clinical trial within 3 months prior to screening.
  • 17. Participants who have smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or who cannot refrain from smoking during the study period.
  • 18. Participants with a history of alcohol abuse, or a positive alcohol test at study admission; or participants who cannot abstain from alcohol during the study period.
  • 19. Participants with a history of drug abuse, or a positive urine drug screen.
  • 20. Female participants with a positive pregnancy test, or breastfeeding women.
  • 21. Participants who, based on the Columbia-Suicide Severity Rating Scale at screening, or in the investigator's clinical judgment, are at risk of suicide, or have a history of suicidal or self-injurious behavior.
  • 22. Participants with other factors deemed ineligible to participate in the trial by the Investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    KHN707 tablets

    All participants will receive a single dose or two doses of KHN707 tablets .

    Drug: KHN707 tablet

  • Placebo comparator
    Placebo

    All participants will receive a single dose or two doses of the placebo.

    Drug: Placebo

Interventions

  • DrugKHN707 tablet

    Participants will receive a single dose or two doses of KHN707 tablets orally in a fasting or fed state.

  • DrugPlacebo

    All participants will receive a single dose or two doses of the placebo in a fasting or fed state.

06

What researchers measure

Primary outcomes

  1. The incidence and severity of adverse events (AEs)

    Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc.

    Time frame: From screening to Day 4 .

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    To characterise the PK of KHN707 following oral administration of KHN707.

    Time frame: Day 1 to Day 3.

  2. Time to reach maximum observed concentration (Tmax)

    To characterise the PK of KHN707 following oral administration of KHN707.

    Time frame: Day 1 to Day 3.

  3. Area under plasma concentration-time curve from zero to infinity (AUC0-inf)

    To characterise the PK of KHN707 following oral administration of KHN707.

    Time frame: Day 1 to Day 3.

  4. Terminal elimination half-life (t1/2)

    To characterise the PK of KHN707 following oral administration of KHN707.

    Time frame: Day 1 to Day 3.

  5. Apparent total body clearance (CL/F)

    To characterise the PK of KHN707 following oral administration of KHN707.

    Time frame: Day 1 to Day 3.

  6. Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

    To characterise the PK of KHN707 following oral administration of KHN707.

    Time frame: Day 1 to Day 3.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07557537
Lead sponsor
Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
May 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Chongyuan Xu
Contact
nflcyljd@smu.edu.cn
86-13926186470

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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