Status:
COMPLETED
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Lead Sponsor:
Promentis Pharmaceuticals, Inc.
Collaborating Sponsors:
Celerion
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed th...
Eligibility Criteria
Inclusion
- Healthy adult male or females (women of non child bearing potential), 18-55 years of age (inclusive).
- Medically healthy with no clinically significant screening results.
- Non-vasectomized male subjects must agree to use birth control or abstain from sexual intercourse during and until 90 days beyond the last dose of study drug/placebo.
- Continuous non-smoker, at least 3 months prior to first dose and throughout the study.
- Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol
Exclusion
- Subject is mentally or legally incapacitated.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years
- Female subject of childbearing potential.
- Blood donation or significant blood loss within 56 days prior to first dose.
- Plasma donation within 7 days prior to first dose.
- Participation in another clinical trial within 30 days prior to first dose.
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03301298
Start Date
September 11 2017
End Date
February 13 2018
Last Update
September 26 2019
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283