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CompletedNCT03430232Updated Dec 12, 2018

First-In-Human PainCart Study for STR-324

A Phase 1 interventional study of Placebo and STR-324 Dose Level 1 in Pain, sponsored by Stragen France. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Stragen France · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Pain
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    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.

    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

  • Experimental
    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.

    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

  • Experimental
    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.

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

  • Experimental
    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.

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

  • Experimental
    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.

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

Interventions

  • DrugPlacebo

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

  • DrugSTR-324 Dose Level 1

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level 2

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level 3

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level 4

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level 5

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level 6

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level 7

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level 8

    Short infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level A

    Long infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level B

    Long infusion of a solution for intravenous administration

  • DrugSTR-324 Dose Level C

    Long infusion of a solution for intravenous administration

  • DrugPlacebo

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

05

What researchers measure

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

    Time frame: Day 7 (+/- 2 days) post dosing

Secondary outcomes

  1. Parts I and II: Maximum plasma concentration (Cmax)

    Time frame: Up to 24 hours for Part I and up to 52 hours for Part II

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

    Time frame: Up to 24 hours for Part I and up to 52 hours for Part II

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

    Time frame: Up to 24 hours for Part I and up to 52 hours for Part II

  4. 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)

    Time frame: Up to 24 hours for Part I and up to 52 hours for Part II

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

    Time frame: Up to 24 hours for Part I and up to 52 hours for Part II

  6. Parts I and II: Amount excreted in urine in 24 hours

    Time frame: Up to 24 hours for Part I and up to 72 hours for Part II

  7. Parts I and II: Thermal Pain

    Time frame: Up to 5 hours for part I and up to 56 hours for part II

  8. Parts I and II: Electrical pain Stair and Burst

    Time frame: Up to 5 hours for part I and up to 56 hours for part II

  9. Parts I and II: Pressure Pain

    Time frame: Up to 5 hours for part I and up to 56 hours for part II

  10. Parts I and II: Cold Pressor

    Time frame: Up to 5 hours for part I and up to 56 hours for part II

  11. Parts I and II: Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor)

    Time frame: Up to 5 hours for part I and up to 56 hours for part II

  12. Parts I and II: Visual Analogue Scale Bond & Lader

    Time frame: Up to 5 hours for part I and up to 56 hours for part II

  13. Parts I and II: Visual Analogue Scale Bowdle

    Time frame: Up to 5 hours for part I and up to 56 hours for part II

  14. Part II only: Saccadic eye movement

    Time frame: Up to 56 hours

  15. Part II only: Smooth pursuit eye movement

    Time frame: Up to 56 hours

  16. Part II only: Adaptive tracking

    Time frame: Up to 56 hours

  17. Part II only: Body sway

    Time frame: Up to 56 hours

  18. Part II only: N-Back

    Time frame: Up to 56 hours

  19. Part II only: Pharmaco-EEG: power

    Time frame: Up to 56 hours

  20. Part II only: Pupillometry

    Time frame: Up to 56 hours

  21. Part II only: 49-item Addiction Center Research Inventory

    Time frame: Up to 60 hours

  22. Part II only: Bowel Function Index

    Time frame: Up to day 7

  23. Part II - Groups 2 and 3 only: Thermal pain (Normal skin and erythema skin - UVB)

    Time frame: Up to 24 hours

06

Study locations

1 site
  • CHDR
    Leiden, 2333, Netherlands
07

Registry details

Key details

Study ID
NCT03430232
Lead sponsor
Stragen France
Responsible party
Sponsor
First posted
Feb 12, 2018
Start date
Feb 20, 2018
Primary completion
Nov 7, 2018
Completion
Nov 7, 2018
Last update
Dec 12, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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