A Phase 1 Study of KHN702 Tablets in Healthy Subjects
ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChengdu Kanghong Pharmaceutical Group Co., Ltd.
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
KHN702 tablet or placebo
DrugSubject will receive a single KHN702 tablet or matching placebo orally in fasted state.
KHN702 tablet or placebo
DrugAll participants will receive KHN702 tablet or matching placebo orally once a day for 7 days in fasted state.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: KHN702 tablet-Part IExperimental treatment 1 intervention
Group B: KHN702 tablet-Part IIExperimental treatment 1 intervention
Trial outcomes
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 for Part 1, and Day 10 for Part 2.Secondary outcomes
1
Maximum observed plasma concentration (Cmax)
To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Day 1 to Day 10.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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