Phase 1 Study of KH607 Tablets
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KH607 Tablets in Chinese Healthy Volunteers
Chengdu Kanghong Pharmaceutical Group Co., Ltd.
88 participants
Oct 21, 2023
INTERVENTIONAL
Conditions
Summary
This study was a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) stage. The primary objective was to evaluate the safety and tolerability of KH607 tablets in Chinese healthy volunteers.
Eligibility
Inclusion Criteria2
- Adult, male and female volunteers, 18 to 55 years of age, inclusive.
- Male weight ≥ 50kg, female weight ≥ 45kg, and body mass index ≥ 19 to ≤ 28 kg/m2 at the screening period.
Exclusion Criteria4
- Vulnerable groups include the Investigator and his or her immediate family members (spouse, parents, children, siblings), non-immediate family members involved in the study, or individuals who may be participating under coercion or undue influence.
- Subjects whose C-SSRS suggests that they are at risk for suicide at the screening period, or with the risk for suicide based on the Investigator's clinical judgment, or with a history of suicidal or self-harming behavior.
- Subjects with SSS ≥3 or MOAA/S ≤4 during the screening period.
- Subjects with a history of surgery for gastrointestinal disorders or current GI disorders that may interfere with drug absorption, or who have undergone major surgery within the 3 months prior to the screening period.
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Interventions
Subject receive KH607 tablets or placebo orally single dose.
Subject receive KH607 tablets or placebo orally single dose.
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Subject receive KH607 tablets or placebo orally single dose or multiple doses.
Subject receive KH607 tablets or placebo orally single dose.
Subject receive KH607 tablets or placebo orally single dose.
Subject receive KH607 tablets or placebo orally single dose.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06393803