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

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ClinicalTrials.gov Identifier: NCT03500627
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Orpheris, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: OP-101 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-Acetyl-Cysteine) After Intravenous Administration in Healthy Volunteers
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
20 mg/kg OP-101 administered intravenously for over 1 hour.
Drug: OP-101
Intravenous Injection of OP-101 in healthy volunteers.

Experimental: Cohort 2
40 mg/kg OP-101 administered intravenously for over 1 hour.
Drug: OP-101
Intravenous Injection of OP-101 in healthy volunteers.

Experimental: Cohort 3 (optional)
80 mg/kg OP-101 administered intravenously for over 1 hour.
Drug: OP-101
Intravenous Injection of OP-101 in healthy volunteers.




Primary Outcome Measures :
  1. Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0 [ Time Frame: Screening to Day 15. ]
    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.


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Profile Analysis [ Time Frame: Days 1, 2, 3, 4, 8, and 15. ]
    Determine the PK profile of OP-101 after single IV doses in healthy subjects as determined by plasma concentrations using the PK Concentration Population.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500627


Locations
United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Orpheris, Inc.
Investigators
Study Chair: Stephen Huhn, MD Orpheris, Inc.

Responsible Party: Orpheris, Inc.
ClinicalTrials.gov Identifier: NCT03500627     History of Changes
Other Study ID Numbers: OP-101-002
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Orpheris, Inc.:
Adrenoleukodystrophy (ALD)
Childhood Cerebral Adrenoleukodystrophy (ccALD)
OP-101
Dendrimer
N-Acetyl-Cysteine (NAC)

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes