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

NCT ID: NCT03500627

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2018-07-20

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

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

Group Type: EXPERIMENTAL

OP-101

Intervention Type: DRUG

Intravenous Injection of OP-101 in healthy volunteers.

Cohort 2

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

Group Type: EXPERIMENTAL

OP-101

Intervention Type: DRUG

Intravenous Injection of OP-101 in healthy volunteers.

Cohort 3 (optional)

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

Group Type: EXPERIMENTAL

OP-101

Intervention Type: DRUG

Intravenous Injection of OP-101 in healthy volunteers.

Interventions

OP-101

Intravenous Injection of OP-101 in healthy volunteers.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orpheris, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Huhn, MD

Role: STUDY_CHAIR

Orpheris, Inc.

Locations

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

OP-101-002

Identifier Type: -

Identifier Source: org_study_id