Food Effect of KH607 in Chinese Health ParticipantsPhase 1NCT07634874
A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of KH607 in Healthy Chinese Participants
A Phase 1 study testing KH607 in people with Food Effect of KH607 in Chinese Health Participants, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
Trial summary
This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effect of KH607 in Chinese Health Participants
- What is being tested?
- KH607
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jul 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
- Participants must be healthy and aged ≥18 and <45 years at the time of screening visit.
- Participants must have a body weight equal to or greater than 50 kg (≧45 kg for females ) and a body mass index between 19.0 kg/m2 and 28.0 kg/m2 at the time of screening visit.
- Participants who have no plans for reproduction during the study period and for 3 months following the last dose, must voluntarily agree to use effective and appropriate contraceptive measures, and must have no plans for sperm or egg donation during this period.
- Participant who can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures shall be included
Who cannot join
- Participants with known allergy to any ingredient of KH607; or those with a known history of allergy to drugs of the same class; or those with known allergies to two or more other drugs, foods, or environmental factors; or those known to be prone to allergic symptoms such as rash, urticaria, etc. shall be excluded.
- Participants with diseases of the cardiovascular, nervous, respiratory, urinary, digestive, hematologic, endocrine, or immune systems, or psychiatric disorders (including but not limited to: history of epilepsy, Parkinson's disease or other movement disorders, clinically significant history of syncope or vertigo, and any history of psychiatric disorders), which may affect the safety evaluation of the trial, and who, in the opinion of the investigator, are unsuitable for participation in the trial.
- Participants with a history of vestibular dysfunction or severe motion sickness; or a history of ocular disorders such as glaucoma, retinopathy, or other ophthalmic diseases that may cause blurred vision or exacerbate visual adverse effects and are considered clinically significant by the investigator shall be excluded.
- Participants who are unable to Irefrain from driving vehicles, operating hazardous machinery, or working at heights from the time of signing the informed consent form until 1 week after the last dose shall be excluded.
- Participation who have participated in another clinical trial and received an investigational drug, vaccine, or device within 90 days prior to the first dose shall be excluded.
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 Randomized, Open-Label, 2-period, 2-sequence, Crossover Food-Effect Study of KH607 Tablets in Healthy Chinese Participants
This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under fasting and fed conditions in healthy participants.
- Being tested
- KH607
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH607Drug
KH607, single dose, oral
KH607Drug
KH607, single dose, oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: KH607 | Experimental | period 1: Fasted, Period 2: Fed Receives: Drug: KH607 |
| Sequence B: KH607 | Experimental | period 1: Fed, Period 2: Fasted Receives: Drug: KH607 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Measured: Up to 96 Hours after study drug administration
AUC0-∞
Measured: Up to 96 Hours after study drug administration
Cmax
Measured: Up to 96 Hours after study drug administration
The GMRs and their 90% confidence intervals for AUC0-∞ (or AUC0-t and Cₘₐₓ of KH607 tablets under fasting and fed conditions )
Measured: Up to 96 Hours after study drug administration
Secondary outcomes (6)
Tmax
Measured: Up to 96 Hours after study drug administration
t1/2
Measured: Up to 96 Hours after study drug administration
λz
Measured: Up to 96 Hours after study drug administration
tlag
Measured: Up to 96 Hours after study drug administration
CL/F
Measured: Up to 96 Hours after study drug administration
Safety：Incidence and severity of Adverse Events ( AE)/SAE
Measured: from ICF signing date to day 19 since first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Effect of KH607 in Chinese Health 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT07634874
- Sponsor's protocol ID
- KH607-30104
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 2-period, 2-sequence, Crossover Food-Effect Study of KH607 Tablets in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07634874
- Acronym / sponsor ID
- KH607-30104
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Jun 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 study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under fasting and fed conditions in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: KH607 | Experimental | Drug: KH607period 1: Fasted, Period 2: Fed |
| Sequence B: KH607 | Experimental | Drug: KH607period 1: Fed, Period 2: Fasted |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be healthy and aged ≥18 and <45 years at the time of screening visit.
- Participants must have a body weight equal to or greater than 50 kg (≧45 kg for females ) and a body mass index between 19.0 kg/m2 and 28.0 kg/m2 at the time of screening visit.
- Participants who have no plans for reproduction during the study period and for 3 months following the last dose, must voluntarily agree to use effective and appropriate contraceptive measures, and must have no plans for sperm or egg donation during this period.
- Participant who can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures shall be included
Key exclusion criteria (5 listed)
- Participants with known allergy to any ingredient of KH607; or those with a known history of allergy to drugs of the same class; or those with known allergies to two or more other drugs, foods, or environmental factors; or those known to be prone to allergic symptoms such as rash, urticaria, etc. shall be excluded.
- Participants with diseases of the cardiovascular, nervous, respiratory, urinary, digestive, hematologic, endocrine, or immune systems, or psychiatric disorders (including but not limited to: history of epilepsy, Parkinson's disease or other movement disorders, clinically significant history of syncope or vertigo, and any history of psychiatric disorders), which may affect the safety evaluation of the trial, and who, in the opinion of the investigator, are unsuitable for participation in the trial.
- Participants with a history of vestibular dysfunction or severe motion sickness; or a history of ocular disorders such as glaucoma, retinopathy, or other ophthalmic diseases that may cause blurred vision or exacerbate visual adverse effects and are considered clinically significant by the investigator shall be excluded.
- Participants who are unable to Irefrain from driving vehicles, operating hazardous machinery, or working at heights from the time of signing the informed consent form until 1 week after the last dose shall be excluded.
- Participation who have participated in another clinical trial and received an investigational drug, vaccine, or device within 90 days prior to the first dose shall be excluded.
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 |
|---|---|---|
| KH607KH607, single dose, oral | Drug | Sequence A: KH607 |
| KH607KH607, single dose, oral | Drug | Sequence B: KH607 |
Primary outcome
AUC0-t
Time frame: Up to 96 Hours after study drug administration
AUC0-∞
Time frame: Up to 96 Hours after study drug administration
Cmax
Time frame: Up to 96 Hours after study drug administration
The GMRs and their 90% confidence intervals for AUC0-∞ (or AUC0-t and Cₘₐₓ of KH607 tablets under fasting and fed conditions )
Time frame: Up to 96 Hours after study drug administration
6 secondary outcomes
Tmax
Time frame: Up to 96 Hours after study drug administration
t1/2
Time frame: Up to 96 Hours after study drug administration
λz
Time frame: Up to 96 Hours after study drug administration
tlag
Time frame: Up to 96 Hours after study drug administration
CL/F
Time frame: Up to 96 Hours after study drug administration
Safety：Incidence and severity of Adverse Events ( AE)/SAE
Time frame: from ICF signing date to day 19 since first dose
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes
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 KH607 in people with Food Effect of KH607 in Chinese Health 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 5 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 9 Jun 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. 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 Chang Meng Yang, 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?
AUC0-t (time frame: Up to 96 Hours after study drug administration). The study lists 4 primary outcomes in all. 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 9 Jun 2026.