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Gadoquatrane 0.03 mmol Gd/kg

Phase 1

Contrast Enhancement in Magnetic Resonance Imaging | Small molecule | Other |Bayer AG|Trials 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

Gadoquatrane 0.03 mmol Gd/kg clinical trials

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?

Gadoquatrane 0.03 mmol Gd/kg is an investigational small molecule being developed by Bayer AG as a contrast agent for magnetic resonance imaging (MRI). The 0.03 mmol Gd/kg refers to the gadolinium dose level studied. It is designed to enhance contrast during MRI scans, helping to improve visualization of internal structures.

What is gadoquatrane 0.03 mmol Gd/kg used for?

Gadoquatrane 0.03 mmol Gd/kg is being studied for contrast enhancement in magnetic resonance imaging. It is intended to improve the visibility of tissues and structures during MRI procedures. The clinical program has evaluated it in healthy male volunteers rather than in patients with a specific disease.

Who is developing gadoquatrane 0.03 mmol Gd/kg?

Gadoquatrane 0.03 mmol Gd/kg is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program for this MRI contrast agent candidate.

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 agent and has not been approved by the FDA. The completed Phase 1 trial evaluated single ascending doses in healthy Chinese male participants.

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

Gadoquatrane 0.03 mmol Gd/kg has been studied in one completed Phase 1 trial, NCT06135181. That trial enrolled 24 healthy Chinese male participants aged 18 years and older and assessed safety and blood levels of BAY1747846 after single intravenous doses. It was randomized and controlled.

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

Yes, gadoquatrane 0.03 mmol Gd/kg is the same compound as BAY1747846. BAY1747846 is Bayer's internal code for gadoquatrane, and the 0.03 mmol Gd/kg designation refers to the gadolinium dose level used in the Phase 1 study. Both names refer to the same investigational MRI contrast agent.