Study to Assess PDM608 in Healthy Adult Subjects

Parkinson Disease Clinical Trial

Official title: A Two-Part Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of PDM608 in Healthy Adult Subjects

Status Recruiting

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of PDM608 in healthy adult subjects.

Clinical Trial Description

This is a 2-part, single-center, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of PDM608 in healthy adult subjects.

Part 1 is a double-blind, randomized, placebo-controlled assessment of subcutaneous (SC) SAD administrations of PDM608 across 5 cohorts of subjects. All SAD cohorts will follow a sentinel design. Following completion of each cohort, safety and tolerability data through 96 hours post-dose will be reviewed to determine whether to progress to the next dose level and the dose level for the next cohort.

Part 2 is a double-blind, randomized, placebo-controlled assessment of SC MAD administrations (once weekly for 4 weeks) of PDM608 across up to 4 cohorts of subjects. Following completion of each cohort the safety and tolerability data 96 hours post last dose will be reviewed to determine whether to progress to the next dose level and the dose level to be administered. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05950906
• Study type: Interventional
• Source: Calibr, a division of Scripps Research
• Contact: Zon Wang
• Phone: 425-739-5288
• Email: zonwang@scripps.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: June 27, 2023
• Completion date: April 30, 2024