NCT06105528

A Phase 1a Study of PMN310 In Healthy Volunteers

A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PMN310 Infusions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: ProMis Neurosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This first in human Phase 1a clinical trial will evaluate the safety, tolerability, and pharmacokinetics of a single IV infusion of PMN310 in healthy volunteers.

Detailed description

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses of intravenous PMN310 in healthy adult volunteers. Subjects will be randomly assigned to receive either a single infusion of PMN310 or placebo. After randomization on Day 1, study drug will be administered followed by the collection of safety, tolerability, and PK data. All dose cohorts will have lumbar punctures (LPs) for PK analysis performed on Day 3 and Day 29. Primary PK and CSF data will be obtained from Day 1 to Day 29. Safety and tolerability will be collected at all visits. The study is an 85-day study with one optional follow up assessment at Day 120.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	PMN310	60-minute intravenous infusion
DRUG	Placebo	60-minute intravenous infusion

Timeline

• Start date: 2023-11-18
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-10-27
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study