A Phase 1 Study of KHN707 Tablets in Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChengdu Kanghong Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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..

Trial design

Treatments tested in this trial

  • KHN707 tablet
  • Placebo

Treatment groups

38 Participants
are divided into 2 treatment groups

Locations

This trial has no locations