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A First in Human Study of ORT247 in Healthy Volunteers

NCT06769620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

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

Sponsors & Collaborators

  • Orthogonal Neuroscience Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2023-10-24
Completion
2023-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06769620 on ClinicalTrials.gov