A Phase 1 Study of KHN707 Tablets in Healthy Participants (NCT07557537) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1 Study of KHN707 Tablets in Healthy Participants
38 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* 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:
* 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 p…
What they're measuring
1
The incidence and severity of adverse events (AEs)
Timeframe: From screening to Day 4 .
Trial details
NCT IDNCT07557537
SponsorChengdu Kanghong Pharmaceutical Group Co., Ltd.