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

NCT04808154 | Completed Phase 1

• 1 other identifier: SNP-630-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 days

Secondary Outcomes (1)

• Pharmacokinetic profile of SNP-630

  6 days

Study Arms (1)

test drug

EXPERIMENTAL

Powder for oral solution of SNP-630.

Drug: SNP-630

Interventions

SNP-630 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.

test drug

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinew Pharma Inc.: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SNP-630

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 22, 2021
• Study Start: July 22, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)