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A Phase I Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.
A Phase 1 Single Dose Study to investigate the safety, tolerability and Pharmacokinetic profile of SNP-630 in Health Subjects To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects. This is a phase 1, open-label, single-dose study to assess its safety, tolerability and pharmacokinetic profile of SNP-630 in 14 health volunteers. Subjects will receive oral SNP-630 at a dose of 720 mg to assess its safety, tolerability and pharmacokinetic profile. After written informed consent has been obtained, all screening procedures and tests that establish study eligibility will be performed within 28 days prior to day -1 visit. The primary endpoint is to assess the following variable: Clinical safety observations will include Adverse Events (AEs), vital sign measurements, 12-lead ECG and clinical laboratory assessments. Safety data will be tabulated and where appropriate, analyzed by the use of descriptive statistics. Safety data will be tabulated by system organ class and preferred term and will be further classified by relationship to treatment. The probability of safety events will be estimated and with associated 95% corresponding confidence intervals for each cohort using the binomial distribution. Participants are free to withdraw from participation in the study at any time upon request
Age
20 - 45 years
Sex
ALL
Healthy Volunteers
Yes
Tri-Service General Hospital
Taipei, Taiwan
Start Date
July 22, 2021
Primary Completion Date
August 31, 2021
Completion Date
August 31, 2021
Last Updated
October 11, 2021
28
ACTUAL participants
SNP-630
DRUG
Lead Sponsor
Sinew Pharma Inc.
NCT03587831
NCT03997422
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05479721