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Safety and Pharmacokinetics of GEH200486 in Healthy Volunteers

NCT05569278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-07-06

No results posted yet for this study

Summary

This is a single center, prospective, dose escalation study (4 different dose levels) for a novel magnetic resonance imaging (MRI) contrast agent, in male and female healthy volunteers . The study is primarily designed to collect safety data. In addition, researchers want to learn more about how the novel contrast agent, GEH200486 circulates and is eliminated from the body (pharmacokinetics) after injection in healthy volunteers. Up to 24 healthy volunteers will be enrolled and will each receive a single administration of one of the 4 doses of GEH200486. Each healthy volunteer will stay at the clinical unit for the first 24 hours post injection and return for up to 3 follow-up visits with 1 additional follow-up phone call.

Dose escalation from one dose group to the next dose group will be sequential and only be allowed if the clinical safety of all healthy volunteers from the tested dose group is acceptable, as assessed by an independent safety committee, members of GEHC team and the principal investigator.

Conditions

  • Pharmacokinetics

Interventions

DRUG

GE200486 0.5M Injection

Single administration by intravenous (IV) hand injection without dilution, followed by a 5mL saline flush

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Francois Tranquart, MD, PhD · GE Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2022-11-29
Completion
2022-11-29

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569278 on ClinicalTrials.gov