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Completed

NCT Number: NCT06135181

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

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Hospital

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg

Drug

0.03 mmol Gd/kg by intravenous injection (at 2 mL/s)

Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg

Drug

0.1 mmol Gd/kg by intravenous injection (at 2 mL/s)

Matching Placebo

Drug

0.9% sodium chloride by intravenous injection (at 2 mL/s)

Primary outcomes

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

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

    Including severity of TEAE

Secondary outcomes

  1. Cmax

    Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4

    Cmax: Maximum observed drug concentration in measured matrix after single dose administration

  2. AUC

    Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4

    AUC: Area under the concentration vs. time curve from zero to infinity after single dose in case AUC cannot be determined reliably for all participants, AUC will be replaced by AUC(0-tlast)

  3. CL

    Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4

    CL: Total body clearance of drug

  4. CL/bw

    Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.

    CL/bw: Total body clearance of drug normalized by body weight

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study of Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Healthy Chinese Men

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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