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Gadoquatrane 0.03 mmol Gd/kg

Phase 1

Contrast Enhancement in Magnetic Resonance Imaging | Small molecule | Other |Bayer AG|Last Updated: Nov 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Gadoquatrane 0.03 mmol Gd/kg · 1 trial · 2 indications

Phase 1 1
NCT06135181A 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 ParticipantsContrast Enhancement in Magnetic Resonance Imaging
COMPLETED24 Analytics
PHASE1COMPLETED
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
Contrast Enhancement in Magnetic Resonance ImagingUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment-emergent adverse events (TEAE)
From drug administration up to 7 days after end of test drug administration (from day 1 to day 8)

Including severity of TEAE

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
0.03 mmol Gd/kg BAY1747846 and matching placeboEXPERIMENTAL12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo
0.1 mmol Gd/kg BAY1747846 and matching placeboEXPERIMENTAL12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo

Interventions

NameTypeDescription
Gadoquatrane (BAY1747846) 0.03 mmol Gd/kgDRUG0.03 mmol Gd/kg by intravenous injection (at 2 mL/s)
Gadoquatrane (BAY1747846) 0.1 mmol Gd/kgDRUG0.1 mmol Gd/kg by intravenous injection (at 2 mL/s)
Matching placeboDRUG0.9% sodium chloride by intravenous injection (at 2 mL/s)
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 pote...

Countries:China
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Frequently asked questions about Gadoquatrane 0.03 mmol Gd/kg

What is Gadoquatrane 0.03 mmol Gd/kg used for?

Gadoquatrane 0.03 mmol Gd/kg is used for contrast enhancement in magnetic resonance imaging (MRI). It is an investigational small molecule being developed by Bayer AG. The drug is administered as an injection into the vein to improve the visibility of structures during MRI scans.

Who makes Gadoquatrane 0.03 mmol Gd/kg?

Gadoquatrane 0.03 mmol Gd/kg is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is being studied for use in contrast enhancement in magnetic resonance imaging.

What phase is Gadoquatrane 0.03 mmol Gd/kg in?

Gadoquatrane 0.03 mmol Gd/kg is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for contrast enhancement in magnetic resonance imaging.

What clinical trials is Gadoquatrane 0.03 mmol Gd/kg in?

Gadoquatrane 0.03 mmol Gd/kg has one completed clinical trial, identified as NCT06135181. This Phase 1 study evaluated the safety and blood levels of BAY1747846, given as an injection into the vein at increasing single doses in Chinese healthy male participants.

Is Gadoquatrane 0.03 mmol Gd/kg the same as BAY1747846?

Yes, Gadoquatrane 0.03 mmol Gd/kg is also known as BAY1747846. The clinical trial NCT06135181, which studied this drug, used the name BAY1747846 to refer to the investigational agent being evaluated for contrast enhancement in magnetic resonance imaging.