First-In-Human PainCart Study for STR-324

Summary

This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.

Conditions

• Pain

Interventions

DRUG

Placebo

Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%

DRUG

STR-324 Dose Level 1

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level 2

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level 3

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level 4

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level 5

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level 6

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level 7

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level 8

Short infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level A

Long infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level B

Long infusion of a solution for intravenous administration

DRUG

STR-324 Dose Level C

Long infusion of a solution for intravenous administration

DRUG

Placebo

Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Sponsors & Collaborators

• Stragen France

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-20

Primary Completion

2018-11-07

Completion

2018-11-07

Countries

• Netherlands

Study Locations