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HealthyPhase 1NCT07044960

A Phase 1 Study of KHN702 Tablets in Healthy Subjects

A Phase 1 study of Healthy, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers（HVs). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
No sites listed yet
Study dates
21 Jun 2025to 1 Apr 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. exclusion criteria：
  • Have clinically significant medical history or clinical manifestations, including but not limited to the history of any clinically serious disease such as hematological system, circulatory system,digestive system, urinary system, respiratory system, central nervous system,immunology, endocrine system cardiovascular system, malignant tumors, metabolic abnormalities, or any other disease or physiological condition that may interfere with the results .
  • Subjects with clinically significant abnormalities in vital signs, physical examination, 12 lead electrocardiogram, laboratory examination, abdominal color Doppler ultrasound and chest X-ray during screening period, as determined by the investigator.
  • Dysphagia or history of gastrointestinal diseases, liver and kidney diseases that can affect the pharmacokinetic behavior of drugs as judged by the investigator.
Show all 25Show fewer
  • Had surgery within 3 months before screening, or planned surgery during the study period, or had surgery that would affect drug absorption, distribution, metabolism, and excretion.
  • Allergic to the IMP or its excipients, or allergic to two or more other drugs, food and environment, or prone to skin rash, urticaria and other allergic symptoms.
  • Allergic to natural light / UV, or phototoxic reaction after previous use of specific drugs (such as fluoroquinolones and tetracyclines).
  • There are risk factors for cardiac disease, including but not limited to congenital long QT syndrome, torsade de pointes or torsade de pointes (such as hypokalemia, hypomagnesemia, family history of long QT syndrome). Currently, class IA [such as quinidine or procainamide] or class III [such as amiodarone or sotalol] antiarrhythmic drugs or other drugs known to affect QT interval are used. Or QTc interval (QTCF) corrected according to fridericia's criteria > 450 ms in males and > 470 ms in females at screening or other 12 lead ECG abnormalities with clinical significance.
  • Alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) and / or total bilirubin (TBIL), or serum creatinine (CR) exceeded the upper limit of normal at screening.
  • Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody at Screening.
  • Systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg at screening.
  • Vaccinated within 30 days before screening.
  • Any drugs that affects the absorption, metabolism or elimination of the drug has been used within 30 days before administration.
  • Any drugs or health care products (including Chinese herbal medicine and vitamins) used within 14 days before the first administration of the study.
  • Have special requirements for diet and cannot comply with the unified diet.
  • Consumption of foods or juices containing alcohol or caffeine, or having strenuous exercise, or other factors affecting the absorption, distribution, metabolism, excretion of drugs with 48 hours before the first dose. Or disagree to stop drinking tea, coffee and / or caffeinated beverages and foods during the trial.
  • Average daily smoking of more than 5 cigarettes within the 3 months prior to screening or refuse to abstain from smoking during the trial.
  • A history of alcohol abuse or alcohol abuse within 6 months before screening (defined as an average intake of alcohol > 14 units per week, 1 unit ≈ 285 ml of beer with an alcohol content ≥ 3.5%, or 25 ml of spirits with an alcohol content ≥ 40%, or 85 ml of wines with an alcohol content ≥ 12%), or a positive alcohol test at the screening, or unable to abstain from alcohol during the trial.
  • Donation of blood or significant blood loss ≥ 400 mL in 3 month prior to screening.
  • Substance abuse-related disorder or a history of drug, or positive drug screen at screening and Day -1.
  • Positive pregnancy test, or lactating women.
  • Participate in other clinical trials within 3 months before screening (participation refers to receiving drug administration or device treatment for the trial).
  • Subjects with other factors deemed ineligible to participate in the trial by the Investigator.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mengchang Yang Sichuan Provincial People's Hospital, Medical Doctor contact

86-28-87393401

ymc681@126.com

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KHN702 Tablets in Chinese Healthy Volunteers

This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers（HVs).

Read the detailed description

This study consists of two parts: Part 1-SAD phase and Part 2- MAD phase. There will be 7 cohorts in Part 1 and 3 cohorts in Part 2.

The SAD study will enroll approximately 54 HVs across 7 dose cohorts. All participants in Part 1 will be administered with a single oral dose of KHN702 or its matching placebo under fasted condition.

Approximately 30 HVs will be enrolled in the multiple ascending dose study. All participants in Part 2 will received KHN702 or placebo once daily for continuous 7 days (QD x 7d) in a double-blind manner.

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
Being tested
KHN702 tablet or placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KHN702 tablet or placeboDrug

    Subject will receive a single KHN702 tablet or matching placebo orally in fasted state.

  • KHN702 tablet or placeboDrug

    All participants will receive KHN702 tablet or matching placebo orally once a day for 7 days in fasted state.

Study groups in NCT07044960
Study groupRoleWhat they receive
KHN702 tablet-Part IExperimentalAll participants will receive single dose of KHN702 tablet or placebo.
Receives: Drug: KHN702 tablet or placebo
KHN702 tablet-Part IIExperimentalAll participants will receive mutiple doses of KHN702 tablet or placebo.
Receives: Drug: KHN702 tablet or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From screening to Day 4 for Part 1, and Day 10 for Part 2.

Secondary outcomes (7)

  1. Maximum observed plasma concentration (Cmax)

    To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.

    Measured: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

  2. Time to reach maximum observed concentration (Tmax)

    To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.

    Measured: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

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

    To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.

    Measured: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

  4. Area under the plasma concentration-curve across the dosing interval (AUC0-tau)

    To characterise the steady state PK of KHN702 following oral multiple administration of KHN702.

    Measured: Day 1 to Day 10.

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

    To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.

    Measured: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

  6. Apparent total body clearance (CL/F)

    To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.

    Measured: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

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

    To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.

    Measured: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start21 Jun 2025 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07044960
Sponsor's protocol ID
KHN702-30101
Status last verified
Jun 2025
First submitted
23 Jun 2025
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy, 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 25 inclusion and 0 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 1 Jul 2025. 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. 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 Mengchang Yang Sichuan Provincial People's Hospital, Medical Doctor (86-28-87393401, ymc681@126.com), 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 for Part 1, and Day 10 for Part 2.). 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 NCT07044960.

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 1 Jul 2025.

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