CompletedPhase 1

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

China24 participantsStarted 2020-08-26

Plain-language 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 given at increasing single doses * the level of BAY1747846 in the blood over time when given at increasing single doses. To answer the first question, the researchers compared the number and severity of medical problems the Chinese participants had after receiving BAY1747846 at increasing doses and placebo respectively. Doctors kept tracking of all medical problems that happened in the study, even if they did not think they might be related to the study treatments. To answer the second question, the researchers determined: * the (average) total level of BAY1747846 in the blood, also called AUC * the (average) highest level of BAY1747846 in the blood, also called Cmax * how BAY1747846 is removed from the blood, also called clearance (CL).

Who can participate

Age range18 Years – 45 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 hemoglobi…

What they're measuring

Number of participants with treatment-emergent adverse events (TEAE)

Timeframe: From drug administration up to 7 days after end of test drug administration (from day 1 to day 8)

Trial details

NCT IDNCT06135181

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-02