Status:
UNKNOWN
Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects
Lead Sponsor:
Xoc Pharmaceuticals
Conditions:
Migraine
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fastin...
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fastin...
Eligibility Criteria
Inclusion
- Major
- Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening.
- Body mass index (BMI) ≥ 18 and ≤ 30.0 kg/m2 at screening.
- Medically healthy with no clinically significant finding in medical history, physical examination, laboratory profiles, vital signs, or ECGs, as judged by the PI or designee. Creatinine must be within the upper limit of normal at screening.
- Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
- Major
Exclusion
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
- History of any illness that, in the opinion of the PI or designee, 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 lightheadedness, dizziness or syncope in the 12 months prior to screening.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04104399
Start Date
October 8 2019
End Date
March 30 2022
Last Update
September 23 2021
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283