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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: OP-101

• Registration Number: NCT03500627
• Lead Sponsor: Orpheris, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-27
• Study Start: 2018-03-30
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-18
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	OP-101	20 mg/kg OP-101 administered intravenously for over 1 hour.
Cohort 2	OP-101	40 mg/kg OP-101 administered intravenously for over 1 hour.
Cohort 3 (optional)	OP-101	80 mg/kg OP-101 administered intravenously for over 1 hour.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0	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

Name	Time	Method
Pharmacokinetic (PK) Profile Analysis	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.

Trial Locations

Locations (1)

Medpace Clinical Pharmacology Unit; 🇺🇸 Cincinnati, Ohio, United States