Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR1-365

Phase 1

Recruiting

• Conditions: eurodegenerative disease; inflammatory disease; Neurodegenerative disease; Neurological - Alzheimer's disease; Neurological - Parkinson's disease; Neurological - Other neurological disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders; Neurological - Multiple sclerosis; Renal and Urogenital - Other renal and urogenital disorders; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12619001756112
• Lead Sponsor: Sironax Aus Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-10
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Are capable of signing informed consent form (ICF) and complying with study procedures;
2.Women of childbearing potential (WOCBP) must have a negative pregnancy test and be practicing a medically acceptable method of contraception. All male patients with female partners of child-bearing potential must use two acceptable methods of contraception, during and for 3 months after participation in the study.
3.Nonsmoker, defined as not having smoked more than 2 cigarettes a day during the 6 months before screening. During the study, subject should be able to limit the use of tobacco products to 2 cigarettes a day;
4.Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing through the end of the study;
5.Able to limit the consumption of coffee and any caffeine-containing products to four cups a day during the study;
6.Body mass index (BMI) of 18 to 32 kg/m2 inclusive and body weight not less than 50 kg;

Exclusion Criteria

1.Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
2.Clinically significant findings of screening clinical safety laboratory tests
3.Subjects with a mean systolic blood pressure of three measurements >150 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening. Blood pressure will be measured at sitting position
4.Known or suspected malignancy, except adequately treated basal cell carcinoma
5.Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
6.A history of seizure. However, a history of febrile seizure is allowed
7.A hospital admission or major surgery within 60 days prior to screening
8.Participation in any other investigational drug trial within 30 days prior to screening
9.DSM-V substance use disorders within 6 months prior to screening
10.A positive result for alcohol or drugs of abuse at screening or admission.
11.Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 30 days prior to screening
12.Use of prescription or over-the-counter (OTC) medications, and herbal medicines within 30 days prior to dosing
13.A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant history of risk of suicide or homicide

Study & Design

• Study Type: Interventional
• Study Design: Not specified