Conditions: Healthy Volunteers Brain Lesion
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 142
Healthy volunteers: yes

Brief 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.

Detailed description:
This single-center, single ascending dose, phase I/IIa study was divided into 2 parts, involving both healthy subjects and patients with brain lesions:

* Study Part I included healthy subjects: double-blind, randomized, placebo control;
* Study Part II included patients with brain lesions: open-label.

In Part I, the following 6 dosing groups were investigated:

* Group 1: 0.025 mmol/kg
* Group 2: 0.05 mmol/kg
* Group 3: 0.075 mmol/kg
* Group 4: 0.1 mmol/kg
* Group 5: 0.2 mmol/kg
* Group 6: 0.3 mmol/kg

Healthy subjects were included and were then administered with P03277 or placebo and were to undergo MRI examination according to the randomization scheme.

In Part II, the following 4 doses groups were investigated:

* Group 7: 0.05 mmol/kg
* Group 8: 0.075 mmol/kg
* Group 9: 0.1 mmol/kg
* Group 10: 0.2 mmol/kg

Patients with brain lesions were included and were then administered with P03277 and underwent MRI examination.

Arms:
arm 1: In each dose group (0.025, 0.05, 0.075, 0.1, 0.2 and 0.3 mmol/kg), 9 healthy subjects were to be included: 6 subjects received P03277 and 3 subjects received placebo in one single intravenous administration. arm 2: In each dose group (0.05, 0.075, 0.1 and 0.2 mmol/kg), all 3 patients received one single intravenous administration of P03277.

Interventions: intervention 1: P03277 intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: