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CompletedNCT03500627Updated Sep 17, 2018

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 After Intravenous Administration in Healthy Volunteers

A Phase 1 interventional study of OP-101 in Healthy, sponsored by Orpheris, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-17.

Sponsored by Orpheris, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2018, 8 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.

02

Conditions studied

  • Healthy

Keywords

  • Adrenoleukodystrophy (ALD)
  • Childhood Cerebral Adrenoleukodystrophy (ccALD)
  • OP-101
  • Dendrimer
  • N-Acetyl-Cysteine (NAC)
03

In context

Lead sponsor

Orpheris, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • Body Mass Index (BMI) between 18 and 32 kg/m\^2.
  • Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG), as judged by the investigator.
  • Female subjects may not be pregnant, lactating, or breastfeeding.
  • Subjects must have a negative urine test for drugs of abuse, cotinine, and breath alcohol test at screening and Check-in.

Key Exclusion Criteria:

  • Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease, or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
  • History of malignancy (other than successfully treated basal cell or squamous cell skin cancer).
  • History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant.
  • Has used any product containing nicotine within 90 days prior to screening or intends to use any product containing nicotine during the course of the study.
  • Has used medications that affect gastrointestinal motility or gastric emptying; such as metoclopramide, proton pump inhibitors, and H2 blockers; within 30 days prior to Day 1.
  • Has used prescription or over-the-counter medication, vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days prior to Day 1.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Cohort 1

    20 mg/kg OP-101 administered intravenously for over 1 hour.

    Drug: OP-101

  • Experimental
    Cohort 2

    40 mg/kg OP-101 administered intravenously for over 1 hour.

    Drug: OP-101

  • Experimental
    Cohort 3 (optional)

    80 mg/kg OP-101 administered intravenously for over 1 hour.

    Drug: OP-101

Interventions

  • DrugOP-101

    Intravenous Injection of OP-101 in healthy volunteers.

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0

    Evaluate the safety and tolerability of OP-101 after single IV doses in healthy subjects by monitoring and documenting all adverse events, which include laboratory test variables.

    Time frame: Screening to Day 15.

Secondary outcomes

  1. Pharmacokinetic (PK) Profile Analysis

    Determine the PK profile of OP-101 after single IV doses in healthy subjects as determined by plasma concentrations using the PK Concentration Population.

    Time frame: Days 1, 2, 3, 4, 8, and 15.

07

Study locations

1 site
  • Medpace Clinical Pharmacology Unit
    Cincinnati, Ohio 45227, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03500627
Lead sponsor
Orpheris, Inc.
Responsible party
Sponsor
First posted
Apr 18, 2018
Start date
Mar 30, 2018
Primary completion
Jul 20, 2018
Completion
Jul 20, 2018
Last update
Sep 17, 2018

Study contacts

Stephen Huhn, MD
study chair · Orpheris, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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