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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03500627
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Orpheris, Inc.

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE March 30, 2018
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 After Intravenous Administration in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: OP-101
Intravenous Injection of OP-101 in healthy volunteers.
Study Arms  ICMJE
  • Experimental: Cohort 1
    20 mg/kg OP-101 administered intravenously for over 1 hour.
    Intervention: Drug: OP-101
  • Experimental: Cohort 2
    40 mg/kg OP-101 administered intravenously for over 1 hour.
    Intervention: Drug: OP-101
  • Experimental: Cohort 3 (optional)
    80 mg/kg OP-101 administered intravenously for over 1 hour.
    Intervention: Drug: OP-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2018)
12
Actual Study Completion Date  ICMJE July 20, 2018
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03500627
Other Study ID Numbers  ICMJE OP-101-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orpheris, Inc.
Study Sponsor  ICMJE Orpheris, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Stephen Huhn, MD Orpheris, Inc.
PRS Account Orpheris, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP