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

NCT06135181 | Completed Phase 1

• 1 other identifier: 19730
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Contrast Enhancement in Magnetic Resonance Imaging; Healthy Volunteers

Keywords

Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

  Including severity of TEAE

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

Secondary Outcomes (4)

• Cmax

  Pre-dose, on Day 1, Day 2, Day 3 and Day 4

• AUC

  Pre-dose, on Day 1, Day 2, Day 3 and Day 4

• CL

  Pre-dose, on Day 1, Day 2, Day 3 and Day 4

• CL/bw

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

Study Arms (2)

0.03 mmol Gd/kg BAY1747846 and matching placebo

EXPERIMENTAL

12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo

Drug: Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg; Drug: Matching placebo

0.1 mmol Gd/kg BAY1747846 and matching placebo

EXPERIMENTAL

12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo

Drug: Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg; Drug: Matching placebo

Interventions

Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg DRUG

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

0.03 mmol Gd/kg BAY1747846 and matching placebo

Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg DRUG

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

0.1 mmol Gd/kg BAY1747846 and matching placebo

Matching placebo DRUG

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

0.03 mmol Gd/kg BAY1747846 and matching placebo; 0.1 mmol Gd/kg BAY1747846 and matching placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Beijing Hospital

Beijing, 100730, China

Location

Related Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-group, consecutive cohort, escalating single-dose study design

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: August 26, 2020
• Primary Completion: February 2, 2021
• Study Completion: April 30, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)