Status:
UNKNOWN
Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects
Lead Sponsor:
Xoc Pharmaceuticals
Collaborating Sponsors:
Celerion
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each coh...
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel group SAD study conducted at one study center. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In ea...
Eligibility Criteria
Inclusion
- Major
- Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age.
- Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs.
- Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
- Major
Exclusion
- Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical, surgical or psychiatric condition or disease.
- 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 subject by their participation in the study.
- History of clinically significant hypotension.
- History of orthostatic hypotension in the 12 months prior to screening.
- Clinically significant hypertension at screening.
- History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.
Key Trial Info
Start Date :
August 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04043338
Start Date
August 11 2019
End Date
April 30 2022
Last Update
September 23 2021
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283