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First-In-Human PainCart Study for STR-324

NCT ID: NCT03430232

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2018-11-07

Brief Summary

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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.

Detailed Description

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Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

For part I: crossover model For part II: parallel model
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part I (Panel 1): STR-324 or placebo

Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

STR-324 Dose Level 1

Intervention Type DRUG

Short infusion of a solution for intravenous administration

STR-324 Dose Level 3

Intervention Type DRUG

Short infusion of a solution for intravenous administration

STR-324 Dose Level 5

Intervention Type DRUG

Short infusion of a solution for intravenous administration

STR-324 Dose Level 7

Intervention Type DRUG

Short infusion of a solution for intravenous administration

Part I (Panel 2): STR-324 or placebo

Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

STR-324 Dose Level 2

Intervention Type DRUG

Short infusion of a solution for intravenous administration

STR-324 Dose Level 4

Intervention Type DRUG

Short infusion of a solution for intravenous administration

STR-324 Dose Level 6

Intervention Type DRUG

Short infusion of a solution for intravenous administration

STR-324 Dose Level 8

Intervention Type DRUG

Short infusion of a solution for intravenous administration

Part II (Panel 1): STR-324 or placebo

Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization.

Group Type EXPERIMENTAL

STR-324 Dose Level A

Intervention Type DRUG

Long infusion of a solution for intravenous administration

Placebo

Intervention Type DRUG

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

Part II (Panel 2): STR-324 or placebo

Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization.

Group Type EXPERIMENTAL

STR-324 Dose Level B

Intervention Type DRUG

Long infusion of a solution for intravenous administration

Placebo

Intervention Type DRUG

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

Part II (Panel 3): STR-324 or placebo

Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.

Group Type EXPERIMENTAL

STR-324 Dose Level C

Intervention Type DRUG

Long infusion of a solution for intravenous administration

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

STR-324 Dose Level 1

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level 2

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level 3

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level 4

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level 5

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level 6

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level 7

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level 8

Short infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level A

Long infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level B

Long infusion of a solution for intravenous administration

Intervention Type DRUG

STR-324 Dose Level C

Long infusion of a solution for intravenous administration

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent prior to any study-mandated procedure
* Healthy male subjects, 18 to 45 years of age, inclusive at screening.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
* All males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.
* Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria

* Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
* Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters
* Abnormal renal function (eGFR (MDRD) \< 60 mL/min/1.73m2).
* Previous history of seizures or epilepsy.
* Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day.
* Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies, Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
* Use of any medications (prescription or over-the-counter \[OTC\]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Participation in an investigational drug or device study within 3 months prior to first dosing.
* History of abuse of addictive substances or current use of substances (alcohol, illegal substances)
* Positive test for drugs of abuse or alcohol breath test at screening or pre-dose.
* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
* Loss or donation of blood over 500 mL within three months prior to screening
* Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold or pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stragen France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHDR

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2014-002402-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

STR-324-CL-039

Identifier Type: -

Identifier Source: org_study_id