NCT06769620

A First in Human Study of ORT247 in Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Intravenous ORT247 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Orthogonal Neuroscience Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single center, double-blinded, randomized, placebo controlled single ascending dose clinical study, with the primary purpose of evaluating the safety, tolerability, pharmacokinetics (PK), and immunohistochemistry of escalating intravenous doses of ORT247 in healthy volunteers.

Detailed description

This is a phase 1, first in human, study of ORT247

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

Type	Name	Description
DRUG	ORT247	ORT247 will be provided to study sites in single-use, sterile vials for infusion. Each dose will be prepared with normal saline for infusion.
DRUG	Placebo	Placebo consists of normal saline

Timeline

• Start date: 2022-06-06
• Primary completion: 2023-10-24
• Completion: 2023-10-24
• First posted: 2025-01-10
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study