Back to resultsA Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
SNP-630
Sponsored by
About this trial
This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis
Eligibility Criteria
Inclusion Criteria:
A subject can participate in the study only if all the following criteria are met:
- Between 20 and 45 years
- Body weight 55 - 95 kg and body mass index (BMI) within the range 19 - 30 kg/m2
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG. (A subject with a clinically insignificant abnormality or laboratory parameter(s) may be included only if the Investigator documents that the finding is unlikely to represent a safety risk and will not interfere with the study procedures.)
- Male or Female of non-reproductive potential
Able to provide written informed consent, and understand and comply with the requirements of the study
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible to enter the study:
- History of any significant medical condition (e.g. Cardiovascular, pulmonary, metabolic, renal, gastrointestinal, urological, psychological disease, etc.)
- With any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion
- History of liver disease, or known hepatic or biliary abnormalities
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test (anti-HBc Ab) result at screening
- AST, ALT, gamma-GT and total bilirubin >1.0x ULN
- Creatinine >1.0 x ULN
- Donation of blood or blood products in excess of 500 mL within 3 months
- Has participated in a clinical trial and has received an investigational product within 3 months prior to dosing
- Pregnant or lactating
- Anticipated requirement for any prescription medication during the study.
- History of sensitivity to any of the study medications, or components thereof or a history of anaphylaxis or severe allergy to drug or other substances
- History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years
Sites / Locations
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
test drug
Arm Description
Powder for oral solution of SNP-630.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs):
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Secondary Outcome Measures
Pharmacokinetic profile of SNP-630
Concentrations of SNP-630 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of SNP-630 and its metabolites in health subjects oral SNP-630 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04808154
Brief Title
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
Official Title
A Phase I Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinew Pharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
SNP-630
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test drug
Arm Type
Experimental
Arm Description
Powder for oral solution of SNP-630.
Intervention Type
Drug
Intervention Name(s)
SNP-630
Intervention Description
Subjects will receive one single dose of SNP-630 at Day 1. Blood and urine samples will be obtained to determine the PK of orally administered SNP-630.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs):
Description
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile of SNP-630
Description
Concentrations of SNP-630 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of SNP-630 and its metabolites in health subjects oral SNP-630 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method.
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A subject can participate in the study only if all the following criteria are met:
Between 20 and 45 years
Body weight 55 - 95 kg and body mass index (BMI) within the range 19 - 30 kg/m2
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG. (A subject with a clinically insignificant abnormality or laboratory parameter(s) may be included only if the Investigator documents that the finding is unlikely to represent a safety risk and will not interfere with the study procedures.)
Male or Female of non-reproductive potential
Able to provide written informed consent, and understand and comply with the requirements of the study
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible to enter the study:
History of any significant medical condition (e.g. Cardiovascular, pulmonary, metabolic, renal, gastrointestinal, urological, psychological disease, etc.)
With any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion
History of liver disease, or known hepatic or biliary abnormalities
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test (anti-HBc Ab) result at screening
AST, ALT, gamma-GT and total bilirubin >1.0x ULN
Creatinine >1.0 x ULN
Donation of blood or blood products in excess of 500 mL within 3 months
Has participated in a clinical trial and has received an investigational product within 3 months prior to dosing
Pregnant or lactating
Anticipated requirement for any prescription medication during the study.
History of sensitivity to any of the study medications, or components thereof or a history of anaphylaxis or severe allergy to drug or other substances
History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
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