NASH - Nonalcoholic SteatohepatitisPhase 1NCT04808154
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
A Phase 1 study testing SNP-630 in people with NASH - Nonalcoholic Steatohepatitis, run by Sinew Pharma Inc. at 1 site in Taiwan.
Trial summary
To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- SNP-630
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2021to 31 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- SNP-630
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNP-630Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| test drug | Experimental | Powder for oral solution of SNP-630. Receives: Drug: SNP-630 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Secondary outcomes (1)
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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start22 Jul 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SNP-630
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinew Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808154
- Sponsor's protocol ID
- SNP-630-101
- Status last verified
- Oct 2021
- First submitted
- 9 Feb 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
- ClinicalTrials.gov ID
- NCT04808154
- Acronym / sponsor ID
- SNP-630-101
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sinew Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SNP-630
| Arm | Type | Receives |
|---|---|---|
| test drug | Experimental | Drug: SNP-630Powder for oral solution of SNP-630. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A subject can participate in the study only if all the following criteria are met:
Key exclusion criteria (13 listed)
- Subjects who meet any of the following criteria are not eligible to enter the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNP-630Subjects 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. | Drug | test drug |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs):
Time frame: 6 days
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.
1 secondary outcome
Pharmacokinetic profile of SNP-630
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNP-630 in people with NASH - Nonalcoholic Steatohepatitis, run by Sinew Pharma Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.