Healthy Adult ParticipantsPhase 1NCT07557537
A Phase 1 Study of KHN707 Tablets in Healthy Participants
A Phase 1 study testing KHN707 tablet in people with Healthy Adult Participants, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- KHN707 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Oct 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of KHN707 Tablets in Chinese Healthy Volunteers
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.
- Conditions
- Healthy Adult Participants
- Being tested
- KHN707 tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHN707 tabletDrug
Participants will receive a single dose or two doses of KHN707 tablets orally in a fasting or fed state.
PlaceboDrug
All participants will receive a single dose or two doses of the placebo in a fasting or fed state.
| Study group | Role | What they receive |
|---|---|---|
| KHN707 tablets | Experimental | All participants will receive a single dose or two doses of KHN707 tablets . Receives: Drug: KHN707 tablet |
| Placebo | Placebo comparator | All participants will receive a single dose or two doses of the placebo. Receives: Drug: 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 (AEs)
Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc.
Measured: From screening to Day 4 .
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
To characterise the PK of KHN707 following oral administration of KHN707.
Measured: Day 1 to Day 3.
Time to reach maximum observed concentration (Tmax)
To characterise the PK of KHN707 following oral administration of KHN707.
Measured: Day 1 to Day 3.
Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
To characterise the PK of KHN707 following oral administration of KHN707.
Measured: Day 1 to Day 3.
Terminal elimination half-life (t1/2)
To characterise the PK of KHN707 following oral administration of KHN707.
Measured: Day 1 to Day 3.
Apparent total body clearance (CL/F)
To characterise the PK of KHN707 following oral administration of KHN707.
Measured: Day 1 to Day 3.
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To characterise the PK of KHN707 following oral administration of KHN707.
Measured: Day 1 to Day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557537
- Sponsor's protocol ID
- KHN707-30101
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 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, and Pharmacokinetic Profile of KHN707 Tablets in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07557537
- Acronym / sponsor ID
- KHN707-30101
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Apr 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 study . The objective is to evaluate the safety , tolerability and PK profile of KHN707 tablets in Chinese healthy participants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHN707 tablets | Experimental | Drug: KHN707 tabletAll participants will receive a single dose or two doses of KHN707 tablets . |
| Placebo | Placebo comparator | Drug: PlaceboAll participants will receive a single dose or two doses of the placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
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 |
|---|---|---|
| KHN707 tabletParticipants will receive a single dose or two doses of KHN707 tablets orally in a fasting or fed state. | Drug | KHN707 tablets |
| PlaceboAll participants will receive a single dose or two doses of the placebo in a fasting or fed state. | Drug | Placebo |
Primary outcome
The incidence and severity of adverse events (AEs)
Time frame: From screening to Day 4 .
Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc.
6 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 to Day 3.
Time to reach maximum observed concentration (Tmax)
Time frame: Day 1 to Day 3.
Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: Day 1 to Day 3.
Terminal elimination half-life (t1/2)
Time frame: Day 1 to Day 3.
Apparent total body clearance (CL/F)
Time frame: Day 1 to Day 3.
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: Day 1 to Day 3.
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 29 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KHN707 tablet in people with Healthy Adult Participants, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Chongyuan Xu (86-13926186470, nflcyljd@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (AEs) (time frame: From screening to Day 4 .). 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 29 Apr 2026.