Conditions: Healthy Subjects
Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 157
Healthy volunteers: yes

Brief summary:
A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

Detailed description:
A phase I, single-blind, randomised, placebo-controlled, single centre study to investigate the safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses in healthy male subjects.

Arms:
arm 1: MEDI8111 arm 2: Placebo for MEDI8111

Interventions: intervention 1: MEDI8111 intervention 2: Placebo
Intervention descriptions: intervention 1: MEDI8111 lyophilisate for solution for infusion intervention 2: Placebo for MEDI8111 saline solution for infusion

Protocol document: