Status:
COMPLETED
A Study to Learn More About the Safety and the Blood Level of BAY1747846 Given as Injection Into the Vein at Increasing Single Doses in Chinese Healthy Male Participants
Lead Sponsor:
Bayer
Conditions:
Contrast Enhancement in Magnetic Resonance Imaging
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Chinese healthy male participants: * the safety of BAY1747846 when g...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study specific tests or procedures
- Chinese male between 18 and 45 years (inclusive) at screening visit
- Body mass index (BMI): 18.5 to 30.0 kg/m² (inclusive)
- Body weight (bw): 50 to 90 kg (inclusive)
- Participants of reproductive potential must agree to use adequate contraception whenever having sexual intercourse with a woman of child-bearing potential. This applies for the time period from signing of the ICF to at least 1 week after treatment. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements
- Healthy, based on medical history, physical examination, electrocardiography (ECG), and laboratory tests
Exclusion
- Use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (only use of contraceptives and occasional use of paracetamol, aspirin or ibuprofen is permissible)
- Any severe disease within the last 4 weeks prior to the first study drug administration
- Any clinically relevant finding at the physical examination and chest X ray (posterior-anterior) examination
- Any clinically relevant deviation from reference ranges of the laboratory parameters at screening or alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin exceeding the upper limit of normal range (ULN) by more than 10%, or creatinine above the ULN, or hemoglobin below 12 g/dL
- Vital signs: Pulse rate \<50 or \>90beats/min, Systolic blood pressure \<100 or ≥140 mmHg, Diastolic blood pressure \<60 or ≥90 mmHg, or other abnormal vital signs
- Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any agent (including, but not limited to, any allergen, food, drug, chemical, or contrast agent)
- Family history of hypersensitivity reaction to contrast agent
- Regular alcohol consumption equivalent to \>20 g alcohol per day within 3 months prior to screening
- Smokers who smoke more than 5 cigarettes per day within 3 months prior to screening and/or who cannot refrain from smoking from screening until the end of hospitalization
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06135181
Start Date
August 26 2020
End Date
April 30 2021
Last Update
November 18 2023
Active Locations (1)
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1
Beijing Hospital
Beijing, China, 100730