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
Qualifiers
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
Treatments tested in this trial
- KHN702 tablet or placebo
- KHN702 tablet or placebo
Treatment groups
84 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov