A Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of PBT434 in healthy volunteers.

Phase 1

Completed

• Conditions: Atypical Parkinsonism; Neurological - Parkinson's disease; Idiopathic Parkinson's Disease

• Registration Number: ACTRN12618000541202
• Lead Sponsor: Alterity Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-11
• Study Completion: 2019-05-24
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

SAD and MAD phases require healthy male and female adult volunteers aged between 18 and 55 (n=106 total in this age group).

One cohort of the MAD phase will be conducted in healthy elderly participants. The elderly cohort in MAD will be comprised of healthy male and female (not of childbearing potential) volunteers aged greater than or equal to 65 years (n=10 participants in this age group).

Exclusion Criteria

History or presence of malignancy, clinically relevent medical illness, including cardiovascular, GI, hepatic, renal endocrine, neurologic and psychiatric, systemic allergic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of PBT434 after single and multiple oral dose administration by measuring adverse events (AEs), Physical examination, Vital signs, Safety 12-lead Electrocardiograms (ECGs) and Clinical laboratory values<br>[Single Ascending Dose Phase: Days 1, 2,3, 4, 6 post administration of dose on Day 1<br>Multiple Ascending Dose Phase, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 post administration of first dose on Day 1]