NL-OMON46459
Completed
Not Applicable
A First-in-Human, randomized, double-blind, placebo-controlled ascending dose study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects. - First-In-Human PainCart study for STR-324
ConditionsPain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Stragen France
- Enrollment
- 78
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent prior to any study\-mandated procedure
- •2\. Healthy male subjects, 18 to 45 years of age, inclusive at screening.
- •3\. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
- •4\. 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.
- •5\. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Exclusion Criteria
- •1\. 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 \[(following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature), 12\-lead electrocardiogram (ECG)]. Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
- •2\. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, coagulation and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •3\. Abnormal renal function (eGFR (MDRD) \< 60 v
- •4\. Previous history of seizures or epilepsy.
- •5\. Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day.
- •6\. Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies, Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •7\. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg measured in supine position at screening.
- •8\. Abnormal findings in the resting ECG at screening defined as:
- •\- QTcF\> 450 or \< 300 msec
- •\- Notable resting bradycardia (HR \< 45 bpm) or tachycardia (HR \> 100 bpm)
Outcomes
Primary Outcomes
Not specified
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