First-In-Human PainCart Study for STR-324
Phase 1
Completed
- Conditions
- Pain
- Interventions
- Drug: PlaceboDrug: STR-324 Dose Level ADrug: STR-324 Dose Level BDrug: STR-324 Dose Level CDrug: STR-324 Dose Level 1Drug: STR-324 Dose Level 2Drug: STR-324 Dose Level 3Drug: STR-324 Dose Level 4Drug: STR-324 Dose Level 5Drug: STR-324 Dose Level 6Drug: STR-324 Dose Level 7Drug: STR-324 Dose Level 8
- Registration Number
- NCT03430232
- Lead Sponsor
- Stragen France
- 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.
- Detailed Description
Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 78
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part I (Panel 1): STR-324 or placebo Placebo Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization. Part I (Panel 1): STR-324 or placebo STR-324 Dose Level 1 Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization. Part I (Panel 1): STR-324 or placebo STR-324 Dose Level 3 Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization. Part I (Panel 1): STR-324 or placebo STR-324 Dose Level 5 Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization. Part I (Panel 1): STR-324 or placebo STR-324 Dose Level 7 Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization. Part I (Panel 2): STR-324 or placebo Placebo Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization. Part I (Panel 2): STR-324 or placebo STR-324 Dose Level 2 Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization. Part I (Panel 2): STR-324 or placebo STR-324 Dose Level 4 Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization. Part I (Panel 2): STR-324 or placebo STR-324 Dose Level 6 Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization. Part I (Panel 2): STR-324 or placebo STR-324 Dose Level 8 Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization. Part II (Panel 1): STR-324 or placebo STR-324 Dose Level A Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization. Part II (Panel 3): STR-324 or placebo Placebo Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization. Part II (Panel 1): STR-324 or placebo Placebo Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization. Part II (Panel 2): STR-324 or placebo STR-324 Dose Level B Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization. Part II (Panel 2): STR-324 or placebo Placebo Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization. Part II (Panel 3): STR-324 or placebo STR-324 Dose Level C Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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: Thermal Pain Up to 5 hours for part I and up to 56 hours for part II Part II only: Pupillometry Up to 56 hours Part II - Groups 2 and 3 only: Thermal pain (Normal skin and erythema skin - UVB) Up to 24 hours 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: 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: Pressure Pain Up to 5 hours for part I and up to 56 hours for part II Parts I and II: Cold Pressor Up to 5 hours for part I and up to 56 hours for part II Parts I and II: Visual Analogue Scale Bond & Lader Up to 5 hours for part I and up to 56 hours for part II Part II only: Saccadic eye movement Up to 56 hours Part II only: Smooth pursuit eye movement Up to 56 hours Part II only: Adaptive tracking Up to 56 hours Part II only: Body sway Up to 56 hours Part II only: N-Back Up to 56 hours Part II only: Pharmaco-EEG: power Up to 56 hours Part II only: 49-item Addiction Center Research Inventory Up to 60 hours Part II only: Bowel Function Index Up to day 7 Parts I and II: Amount excreted in urine in 24 hours Up to 24 hours for Part I and up to 72 hours for Part II Parts I and II: Electrical pain Stair and Burst Up to 5 hours for part I and up to 56 hours for part II Parts I and II: Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor) Up to 5 hours for part I and up to 56 hours for part II Parts I and II: Visual Analogue Scale Bowdle Up to 5 hours for part I and up to 56 hours for part II
Trial Locations
- Locations (1)
CHDR
🇳🇱Leiden, Netherlands