First-In-Human PainCart Study for STR-324

NCT03430232 | Completed Phase 1

• 2 other identifiers: STR-324-CL-0392014-002402-21
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability: number of subjects who experience (serious) treatment emergent adverse events, potential clinically changes in vital signs, ECG, holter, physical examinations, laboratory tests and urine production

  Day 7 (+/- 2 days) post dosing

Secondary Outcomes (23)

• Parts I and II: Maximum plasma concentration (Cmax)

  Up to 24 hours for Part I and up to 52 hours for Part II

• Parts I and II:Time to maximum plasma concentration (Tmax)

  Up to 24 hours for Part I and up to 52 hours for Part II

• Parts I and II: Area under the plasma concentration-time curve from zero to infinity(AUC0-inf)

  Up to 24 hours for Part I and up to 52 hours for Part II

• Parts I and II: Area under the plasma concentration-time curve from zero to the last measured concentration above the limit of quantification (AUC0-last)

  Up to 24 hours for Part I and up to 52 hours for Part II

• Parts I and II: Terminal disposition rate constant (λz) with the respective half-life (t½)

  Up to 24 hours for Part I and up to 52 hours for Part II

Study Arms (5)

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

EXPERIMENTAL

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

Drug: Placebo; Drug: STR-324 Dose Level 1; Drug: STR-324 Dose Level 3; Drug: STR-324 Dose Level 5; Drug: STR-324 Dose Level 7

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

EXPERIMENTAL

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

Drug: Placebo; Drug: STR-324 Dose Level 2; Drug: STR-324 Dose Level 4; Drug: STR-324 Dose Level 6; Drug: STR-324 Dose Level 8

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

EXPERIMENTAL

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

Drug: STR-324 Dose Level A; Drug: Placebo

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

EXPERIMENTAL

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

Drug: STR-324 Dose Level B; Drug: Placebo

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

EXPERIMENTAL

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

Drug: STR-324 Dose Level C; Drug: Placebo

Interventions

Placebo DRUG

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

Part I (Panel 1): STR-324 or placebo; Part I (Panel 2): STR-324 or placebo

STR-324 Dose Level 1 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level 2 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level 3 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level 4 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level 5 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level 6 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level 7 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level 8 DRUG

Short infusion of a solution for intravenous administration

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

STR-324 Dose Level A DRUG

Long infusion of a solution for intravenous administration

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

STR-324 Dose Level B DRUG

Long infusion of a solution for intravenous administration

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

STR-324 Dose Level C DRUG

Long infusion of a solution for intravenous administration

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stragen France: lead

Study Sites (1)

CHDR

Leiden, 2333, Netherlands

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For part I: crossover model For part II: parallel model

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 12, 2018
• Study Start: February 20, 2018
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

NL (1)