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
A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
20 mg/kg OP-101 administered intravenously for over 1 hour.
Drug: OP-101
40 mg/kg OP-101 administered intravenously for over 1 hour.
Drug: OP-101
80 mg/kg OP-101 administered intravenously for over 1 hour.
Drug: OP-101
Intravenous Injection of OP-101 in healthy volunteers.
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.
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.
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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Orpheris, Inc.