Testing KH607 tablets for safety in healthy volunteers

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of KH607 Tablets in Chinese Healthy Volunteers

This study is testing the safety of KH607 tablets in healthy volunteers by giving them different doses to see how well they tolerate it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06393803 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the safety and tolerability of KH607 tablets in healthy volunteers through a two-part approach. The first part involves a Single Ascending Dose (SAD) phase with eight cohorts receiving varying single doses of KH607 or a placebo. The second part consists of a Multiple Ascending Dose (MAD) phase, where participants will receive daily doses of KH607 or placebo for seven days. The study also aims to assess the impact of food on the pharmacokinetics of KH607.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a specific weight and BMI range.

Not a fit: Patients with a history of gastrointestinal disorders or those at risk for suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data for KH607, paving the way for its future use in treating various conditions.

How similar studies have performed: While this study is focused on a specific drug, similar studies evaluating the safety of new medications in healthy volunteers have generally shown success.

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.

Where this trial is running

Beijing

• Beijing Anding Hospital Affiliated to Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Ling Song

Conditions Healthy