CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 142 enrolled
Drug / intervention
P03277 +1 moredrug
Likely dose
P03277 intravenous, flow rate 0.5–2 mL/s (Part I) or 2 mL/s (Part II); specific dose not statedAI-extracted
Key inclusion· 6
  • ✓Part I: Age 18–45 years inclusive
  • ✓Part I: BMI 18–30 kg/m² (exclusive of boundaries)
  • ✓Part I: Good health status
  • ✓Part II: Age ≥18 years
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03603106
NCT03603106Phase 2Completed
CompareCT.gov

Assessment of Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

Guerbet·interventional·Posted Jul 27, 2018·Updated May 14, 2021

In Brief

A Phase 2 clinical trial evaluating P03277 and Placebo for Healthy Volunteers and Brain Lesion. Completed, enrolled 142 participants across 1 site.

Detailed Summary

The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers, Brain Lesion
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartNov 25, 2013
Primary CompletionApr 17, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.9 years ago

Interventions

P03277drug

Part I: P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s. Part II: P03277 was administered intravenously with a flow rate of 2 mL/s.

Placebodrug

Part I: Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s. Part II: Placebo was administered intravenously with a flow rate of 2 mL/s.