Status:
COMPLETED
Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers
Lead Sponsor:
XWPharma
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.
Eligibility Criteria
Inclusion
- Healthy male of female participants who are 18 to 55 years of age, inclusive.
- Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.
Exclusion
- Evidence or history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, psychiatric, neurological, immunological, or endocrine disorders, poor vision, or allergic disease including drug allergies, including immediate type hypersensitivity. A history of childhood asthma that has resolved is acceptable.
- Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.
Key Trial Info
Start Date :
November 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04688580
Start Date
November 29 2020
End Date
December 14 2021
Last Update
November 4 2022
Active Locations (1)
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1
CMAX
Adelaide, South Australia, Australia, 5000