Status:
COMPLETED
A Study to Learn How Safe BAY3283142 is When Taken as a Single Dose or as Multiple Doses in Healthy Chinese Participants
Lead Sponsor:
Bayer
Conditions:
Chronic Kidney Disease
Non-proliferative Diabetic Retinopathy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD) or non-proliferative diabetes retinopathy (NPDR). CKD is a long-term condition in which the ability of th...
Eligibility Criteria
Inclusion
- Participants must be 18 to 45 years of age (both inclusive) at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test and 12-lead ECG.
- Race: Chinese
- Body mass index (BMI) within the range 18.0 - 27.9 kg/m² (both inclusive) at screening.
- Body weight of at least 55 kg at screening.
- Male and female, female only allowed in the 5 mg dose group. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion
- Known tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- Systolic blood pressure below 100 mmHg or above 140 mmHg (after 15 minutes of supine rest) at screening.
- Diastolic blood pressure below 60 mmHg or above 90 mmHg (after 15 minutes of supine rest) at screening.
- Heart rate below 50 or above 90 beats per minute (after 15 minutes of supine rest) at screening.
Key Trial Info
Start Date :
July 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06487845
Start Date
July 4 2024
End Date
September 19 2024
Last Update
September 24 2024
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, China, 510405