Phase 1 Study of KH607 Tablets

Launched by CHENGDU KANGHONG PHARMACEUTICAL GROUP CO., LTD. · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called KH607 in healthy volunteers to see how safe and well-tolerated it is. The trial is taking place at one center and involves two parts: one where participants will receive a single dose of the medication and another where they will take multiple doses over time. The researchers are looking for adults aged 18 to 55 who meet specific weight and health criteria to join the study.

To be eligible, volunteers need to be within a certain weight range and have a body mass index (BMI) that’s not too low or too high. However, some individuals, particularly those with a history of suicide risk or certain medical conditions affecting the stomach, cannot participate. If you join the study, you can expect to receive either the KH607 tablets or a placebo (a pill with no active medicine) without knowing which one you have until the end of the trial. This study is currently recruiting participants, and it's an important step in understanding how this new medication works in the body.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult, male and female volunteers, 18 to 55 years of age, inclusive.
• • 2. Male weight ≥ 50kg, female weight ≥ 45kg, and body mass index ≥ 19 to ≤ 28 kg/m2 at the screening period.
• Exclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. Subjects with SSS ≥3 or MOAA/S ≤4 during the screening period.
• • 4. 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.