A Phase 1 single and multiple ascending dose study of YA-101 in Healthy Subjects

Phase 1

Recruiting

• Conditions: Multiple System Atrophy; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12623001117606
• Lead Sponsor: Yoda Pharmaceuticals Aus Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-27
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Subjects 18 to 65 years of age (inclusive) and in good state of health.
2. Must be able to communicate and participate in the whole study.
3. Must provide written informed consent.

Exclusion Criteria

1. Subject who has received any investigational drug, stem cell therapy, or inactivated/live vaccinations within 30 days.
2. Subject who is an employee or immediate family member of the Sponsor or the study site.
3. History of drug, alcohol, or smoking abuse in the past 2 years prior to screening.
4. Tested positive for drug abuse.
5. Unwilling to refrain from the use of any prescription medications.
6. Subject not suitable for multiple venipunctures.
7. Has clinically significant abnormal clinical chemistry, hematology, urinalysis, or tested positive for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at screening.
8. Has clinical history or evidence of allergic, hematological, endocrine, cardiovascular, renal, hepatic, pulmonary, gastrointestinal, neurological, psychiatric disease, or malignancy.
9. Any other condition which is deemed unsuitable for participating in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified