First-In-Human PainCart Study for STR-324

Stragen France

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: STR-324 Dose Level 8; Drug: STR-324 Dose Level 1; Drug: STR-324 Dose Level 7; Drug: STR-324 Dose Level C; Drug: STR-324 Dose Level B; Drug: STR-324 Dose Level 2; Drug: STR-324 Dose Level 3; Drug: STR-324 Dose Level 6; Drug: STR-324 Dose Level 5; Drug: STR-324 Dose Level A; Drug: STR-324 Dose Level 4; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03430232

STR-324-CL-039

2014-002402-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 78 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 5 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: STR-324 Dose Level 7

Drug: STR-324 Dose Level 5

Drug: Placebo

Drug: STR-324 Dose Level 3

Drug: Placebo

Drug: STR-324 Dose Level 1

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

Experimental group

Description:

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

Treatment:

Drug: STR-324 Dose Level 2

Drug: STR-324 Dose Level 6

Drug: Placebo

Drug: STR-324 Dose Level 8

Drug: Placebo

Drug: STR-324 Dose Level 4

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

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

Drug: STR-324 Dose Level A

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

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: STR-324 Dose Level B

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: STR-324 Dose Level C

Drug: Placebo

Drug: Placebo