An Ascending-dose, Randomized, Placebo-controlled, Parallel, Double-blind, Single-dose, First-in-Human Study to Evaluate the Safety and Pharmacokinetics of RECCE®327 in Healthy Male Subjects
- Conditions
- Serious/life-threatening bacterial infectionsInfection - Other infectious diseases
- Registration Number
- ACTRN12621001313820
- Lead Sponsor
- Recce Pharmaceuticals, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 75
To be eligible for enrollment, subjects must meet all of the following inclusion criteria:
1.Healthy male subjects between the ages of 18 and 55 years, inclusive, at Screening.
2.Willing and able to provide written informed consent prior to participating in the study.
3.Able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and understand study procedures.
4.Able to complete all Screening period evaluations, stay in the clinical research facility for the duration of the study, and attend scheduled follow-up visit on Day 7 (EOS). Additional visits may be required if there are any abnormalities that have not returned to Baseline by time of discharge from testing unit on Day 2 or by EOS visit on Day 7.
5.Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and body weight not less than 50 kg.
6.In good general health, free from clinically significant medical or psychiatric illness or disease (in the opinion of the Investigator and as determined by medical/surgical history, physical examination, weight, 12-lead electrocardiogram (ECG), and clinical laboratory tests).
7.Vital signs at Screening must be within the following ranges and stable (measured in supine position after at least 5 minutes of rest):
•Systolic blood pressure (SBP) greater than or equal to 90 and less than or equal to 160 mmHg
•Diastolic blood pressure (DBP) greater than or equal to 50 and less than or equal to 95 mmHg
•Heart rate (HR) greater than or equal to 45 and less than or equal to 100 beats per minute (bpm)
•Note: If vital signs are out of range, the Investigator may obtain one additional reading, so that up to two consecutive assessments are made within 1 hour, and with the volunteer seated quietly during the 5 minutes preceding the assessment.
8.A 12-lead ECG consistent with normal cardiac conduction and function at Screening, including but not limited to: heart rate (HR) between 45 and 100 bpm; QTcF interval less than or equal to 450 ms; and morphology consistent with healthy cardiac conduction and function.
9.Nonsmoker within the previous 6 months (before Screening), and does not use tobacco-containing, or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, e-cigarettes, nicotine patch, or nicotine gum).
10.Has clinical chemistry, hematology, coagulation, and complete urinalysis (fasted for at least 10 hours) results at Screening and at admission within 1.5 times the upper limit of normal (ULN) of the reference range for the testing laboratory. The following laboratory evaluations must be within the limits described below, at Screening and Baseline (admission):
•hemoglobin, hematocrit, reticulocyte count must be within normal limits (WNL);
•total white blood cell (WBC) count must not exceed the ULN; subjects with total WBC count below the lower limit of normal (LLN) may be enrolled at PI discretion (as athletic male healthy volunteers may have physiologically mildly low WBC counts);
•prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen must be WNL;
•blood urea and creatinine must be WNL;
•Glomerular Filtration Rate (GFR) must be greater than or equal to 80 mL/min [as calculated by Cockcroft and Gault formula];
•Urinalysis (UA) must be in range (or negative); abnormal UA results may be allowed upon agreement of PI (or Designee) and Sponsor.
11.Has a negative urine drug, uri
Subjects meeting one or more of the following criteria will be excluded from the study:
1.Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, renal disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the Investigator (or Designee) considers should exclude the subject or that could interfere with the interpretation of the study results.
•Subjects with history of or current condition of any of the following will be excluded: Gilbert’s syndrome, asthma or reactive airway disease (any age), migraine;
•Subjects with history of cholecystectomy or splenectomy, or other completely resolved medical conditions may be included at the discretion of the Investigator (or Designee) and the Sponsor.
2.Has any clinically significant medical condition, physical examination finding, ECG abnormality, or clinically significant abnormal value for clinical chemistry, hematology, coagulation, or urinalysis at Screening or at admission to the study center, as deemed appropriate by the Investigator (or Designee).
3.Has had any history of clotting or coagulation disorder.
4.Has had any history of clinically significant renal disease.
5.History or presence of malignancy within the past 5 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
6.Currently suffers from clinically significant systemic allergic disease, or has a history of significant drug allergies, including but not limited to:
•A history of anaphylactic reaction
•Allergic (histamine-like) reaction due to any drug that led to significant morbidity
•Known hypersensitivity to any component of the formulation of test article (RECCE®327), reference (placebo) article, or pretreatment article(s).
7.Has donated or intends to donate blood or blood products or has had an acute loss of blood (>500 mL) during the 3 months before study drug administration, or intends to donate blood or blood products within 3 months after the completion of the study.
8.Has had an acute, clinically significant illness within 30 days prior to Day 1, or has had a recent febrile illness with an abnormal body temperature within 72 hours prior to admission.
9.Has a history within the past 24 months before Screening of drug abuse (defined as any illicit drug use), or a history of alcohol abuse (defined as alcohol consumption exceeding 10 units per week). One unit of alcohol equals 360 mL (12 oz) of beer, 45 mL (1.5 oz) of liquor, or 150 mL (5 oz) of wine.
10.Has a positive test for alcohol or drugs of abuse at Screening or upon admittance to the testing facility, or is unwilling to abstain from alcohol and drugs of abuse throughout the study.
11.Has a smoking history during the past 6 months before Screening. This includes the use of any nicotine containing substances (e.g., nicotine patch or gum, chewing tobacco, e-cigarettes), or has a positive cotinine test at Screening or at admission, or is unwilling to abstain from these products for the duration of the study.
12.Has used any investigational compound, an experimental medical device, or participated in another clinical trial (randomized subjects only) within 3 months prior to receiving the study drug.
13.If the male subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method