NCT05950906

Study to Assess PDM608 in Healthy Adult Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	PDM608	PDM608 subcutaneous at single or multiple dose(s) assigned by cohort
DRUG	Placebo	Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.

Timeline

• Start date: 2023-06-27
• Primary completion: 2024-03-17
• Completion: 2024-04-19
• First posted: 2023-07-18
• Last updated: 2025-11-18
• Results posted: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study