A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.

NCT ID: NCT04808154

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2021-08-31

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

Conditions

NASH - Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

test drug

Powder for oral solution of SNP-630.

Group Type: EXPERIMENTAL

SNP-630

Intervention Type: DRUG

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.

Interventions

SNP-630

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A subject can participate in the study only if all the following criteria are met:

1. Between 20 and 45 years

2. Body weight 55 - 95 kg and body mass index (BMI) within the range 19 - 30 kg/m2

3. 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.)

4. Male or Female of non-reproductive potential

5. 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:

1. History of any significant medical condition (e.g. Cardiovascular, pulmonary, metabolic, renal, gastrointestinal, urological, psychological disease, etc.)

2. With any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion

3. History of liver disease, or known hepatic or biliary abnormalities

4. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test (anti-HBc Ab) result at screening

5. AST, ALT, gamma-GT and total bilirubin >1.0x ULN

6. Creatinine >1.0 x ULN

7. Donation of blood or blood products in excess of 500 mL within 3 months

8. Has participated in a clinical trial and has received an investigational product within 3 months prior to dosing

9. Pregnant or lactating

10. Anticipated requirement for any prescription medication during the study.

11. 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

12. 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinew Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

SNP-630-101

Identifier Type: -

Identifier Source: org_study_id