Phase 1 Study to Investigate SIR2501 in Healthy Adult Participants

Phase 1

Recruiting

• Conditions: europathies; Neurodegenerative disorders; Neuropathies; Neurological - Neurodegenerative diseases; Neurological - Other neurological disorders

• Registration Number: ACTRN12624000562572
• Lead Sponsor: Sironax Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-03
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Must be capable of giving a signed informed consent
• Participants in good health based on medical history, physical examinations, vital
signs, 12-lead ECGs, clinical laboratory tests as determined by the Investigator.
• Body mass index (BMI) within the range of 18~32 kg/m2 (inclusive) with a minimum
body weight of 50 kg at the screening visit.
• Adhere to effective double barrier contraception or are proven post-menopausal

Exclusion Criteria

•Any clinically significant abnormalities in laboratory test results deemed clinically significant by the Investigator.
•History of non-febrile seizures
•History of a suicide attempt in the past 12 months or being seen by the Investigator as having significant risk of suicide
•Positive pregnancy test at Screening or Day-1
•Active or prior hepatitis B infection or positive test for HIV or Hepatitis C
•History of lactose intolerance
•History of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy that is not well managed and stable.as determined by the Investigator.
•Hospital admission or major surgery within 60 days prior to Screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified