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A First in Human Study of ORT247 in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06769620•Orthogonal Neuroscience Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures
•Male and females, 18 to 65 years of age at time of screening
•1. Female subjects of childbearing potential must not be breastfeeding and must have no plans to become pregnant during the course of the study through 120 days after infusion of study drug. Female subjects of childbearing potential who are heterosexual must agree to use a method of contraception considered to be highly effective (i.e., results in \<1% failure rate when used consistently and correctly) from screening through 120 days after the last dose of study drug
•2. Female subjects of non-childbearing potential must have evidence from their medical history indicating that they are not of childbearing potential and must not currently be breastfeeding.
•Any non-vasectomized male subjects must have agreed to use barrier contraceptives plus spermicide for 200 days after dosing.
•Male subjects must agree not to donate sperm for 200 days after dosing
•Female subjects must agree not to preserve eggs (ova) for 120 days after dosing
•Has not participated in a clinical drug study within 30 days of study start, or within 5 half-lives, unless study blind has been broken and the subject was known to be on placebo
•Body mass index of 18-32

Exclusion Criteria

•Contraindication to undergo LP including international normalized ratio (INR) \>1.4 or other coagulopathy, platelet cell count of \<120,000/μL, infection at the desired LP site, current use of anti-coagulant medication except for low dose aspirin, degenerative arthritis, spinal scoliosis, back surgery, suspected increased intracranial pressure on history or neurologic exam, non-communicating hydrocephalus or intracranial mass, or prior history of spinal mass or trauma
•Any significant acute or chronic medical illness
•Any history of cancer within 5 years of enrollment with the exception of resected skin basal cell carcinoma
•Any major surgery within 4 weeks of study drug administration
•Donation of blood or serum \>500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration
•Inability to undergo venipuncture or tolerate venous access
•Has smoked or used tobacco products within 3 months before study drug administration
•Positive drug screen for alcohol, drugs of abuse, or tobacco
•Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), Diagnostic Criteria for Drug and Alcohol Abuse
•Evidence of any clinically significant neurological or psychiatric disorder that could interfere with study assessments as determined by investigator and sponsor
+6 more criteria

Locations (1)

Worldwide Clinical Trials

San Antonio, Texas, United States

Key Dates

Start Date

June 6, 2022

Primary Completion Date

October 24, 2023

Completion Date

October 24, 2023

Last Updated

January 15, 2025

Enrollment

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

ORT247

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A First in Human Study of ORT247 in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

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