AzTrials
AzTrials

Nonalcoholic SteatohepatitisPhase 1NCT04137055

Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics

A Phase 1 study testing ZSP0678-10mg, ZSP0678-30mg and ZSP0678-60mg in people with Nonalcoholic Steatohepatitis, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
ZSP0678-10mg, ZSP0678-30mg and ZSP0678-60mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteChina
Study dates
19 Nov 2019to 9 Dec 2020
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects are required to meet the following criteria in order to be included in the trial:
  • Signature signed informed consent before the trial, and fully understood the content, process and possible adverse reactions.
  • Subjects must be willing and able to complete the research according to the experimental protocol.
  • Subjects (including partners) are willing to take effective contraceptive measures and have no pregnancy plan during the whole study period until 6 months after drug withdrawal.
  • Male and female subjects aged 18-50 (including 18 and 50)
  • Body weight of male subjects should not be less than 50kg and that of female subjects should not be less than 45kg.Body mass index (BMI) = weight (kg)/height 2 (m2), the range of 19~26kg/m2 (including the critical value);
  • Physical condition:No significant abnormalities in medical history, including cardiovascular system, liver, kidneys, gastrointestinal system, neural system, respiratory system (eg.asthma,asthma induced by exercise,chronic obstructive pulmonary disease), mental, metabolism, etc.
  • Subjects in general good health or No significant abnormalities in the opinion of the investigator as determined by vital signs and a physical examination.

Who cannot join

  • Eligible subjects must not meet any of the following exclusion criteria:
  • Allergic constitution (allergic to many drugs, especially to ingredients similar to the test drug and food)
  • The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
  • Known history of drug or alcohol abuse.(defined as consumption of more than 30g of ethanol a day for male and more than 20 g for female )
  • Subjects who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
  • History of dysphagia or any gastrointestinal illness that affects drug absorption, including a history of frequent nausea or vomiting from any cause, irregular gastrointestinal motility, such as habitual diarrhea, constipation, or irritable bowel syndrome.
Show all 19Show fewer
  • History or presence of any disease or condition known to increase the risk of bleeding, eg.acute gastritis, duodenal ulcer, etc.
  • Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
  • Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal within 14 days prior to screening.
  • History of having any special food(including dragon fruit, mango, grapefruit, etc.),strenuous exercises,or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 14 days prior to screening.
  • Subjects who cannot tolerate standard meals (this clause only applies to subjects participating in food impact studies).
  • Presence of clinically significant abnormalities in ECG or QTcB>450ms in males,or QTcB>470ms in females.
  • Pregnancy or breastfeeding at screening and during the study.All female subjects of childbearing potential must have a negative urine pregnancy test at screening and during the trial.
  • Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
  • Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ),treponema pallidum antibodies at screening.
  • Any acute illness or concomitant medication from screening to first dosing.
  • Have chocolate, any food or beverage that contains caffeine ,xanthine and alcohol within 24 hours prior to dosing.
  • Positive for urine drug screening or history of substance abuse for a period of 5 consecutive years before screening.
  • As judged by the researcher, it is not suitable to join the clinical researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Friendship Hospital Affiliated to Capital Medical Universit

    Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP0678 and the Effect of Food on ZSP0678 Pharmacokinetics in Chinese Healthy Subjects.

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either ZSP0678 or placebo .

Being tested
ZSP0678-10mg, ZSP0678-30mg, ZSP0678-60mg, ZSP0678-120mg, ZSP0678-180mg
Keywords
NASH
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.

  • ZSP0678-10mgDrug

    ZSP0678 tablet administered orally under fasted condition

  • ZSP0678-30mgDrug

    ZSP0678 tablets administered orally under fasted condition

  • ZSP0678-60mgDrug

    ZSP0678 tablets administered orally under fasted condition

  • ZSP0678-120mgDrug

    ZSP0678 tablets administered orally under fasted condition

  • ZSP0678-180mgDrug

    ZSP0678 tablets administered orally under fasted condition

  • ZSP0678-240mgDrug

    ZSP0678 tablets administered orally under fasted condition

  • ZSP0678-320mgDrug

    ZSP0678 tablets administered orally under fasted condition

  • ZSP0678Drug

    ZSP0678 tablets administered orally under fasted or fed condition

  • ZSP0678-Dose 1Drug

    ZSP0678 tablets administered orally once daily for 14 Days

  • ZSP0678-Dose 2Drug

    ZSP0678 tablets administered orally once daily for 14 Days

  • ZSP0678-Dose 3Drug

    ZSP0678 tablets administered orally once daily for 14 Days

  • ZSP0678 PlaceboDrug

    Participants will receive placebo matching to ZSP0678 orally.

Study groups in NCT04137055
Study groupRoleWhat they receive
ZSP0678-10mg (single dose)-Cohort 1ExperimentalZSP0678/Placebo 10mg
Receives: Drug: ZSP0678-10mg; Drug: ZSP0678 Placebo
ZSP0678-30mg (single dose)-Cohort 2ExperimentalZSP0678/Placebo 30 mg Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1.
Receives: Drug: ZSP0678-30mg; Drug: ZSP0678 Placebo
ZSP0678-60mg (single dose)-Cohort 3ExperimentalZSP0678/Placebo 60mg Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2.
Receives: Drug: ZSP0678-60mg; Drug: ZSP0678 Placebo
ZSP0678-120mg (single dose)-Cohort 4ExperimentalZSP0678/Placebo 120mg Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3.
Receives: Drug: ZSP0678-120mg; Drug: ZSP0678 Placebo
ZSP0678-180mg (single dose)-Cohort 5ExperimentalZSP0678/Placebo 180mg Enrollment into Cohort 5 will begin upon assurance of safety for Cohort 4.
Receives: Drug: ZSP0678-180mg; Drug: ZSP0678 Placebo
ZSP0678-240mg (single dose)-Cohort 6ExperimentalZSP0678/Placebo 240mg Enrollment into Cohort 6 will begin upon assurance of safety for Cohort 5.
Receives: Drug: ZSP0678-240mg; Drug: ZSP0678 Placebo
ZSP0678-320mg (single dose)-Cohort 7ExperimentalZSP0678/Placebo 320mg Enrollment into Cohort 7 will begin upon assurance of safety for Cohort 6.
Receives: Drug: ZSP0678-320mg; Drug: ZSP0678 Placebo
ZSP0678 (food effect)-Cohort FEExperimentalPeriod 1: Group A and Group B receive ZSP0678/Placebo under the fasting or fed condition ,respectively on Day1. Period 2: Group A and Group B receive ZSP0678/Placebo under the fed or fasting condition ,respectively on Day8. Enrollment into Cohort FE will begin upon assurance of safety for Cohort 4.
Receives: Drug: ZSP0678; Drug: ZSP0678 Placebo
ZSP0678 Dose1 (multiple doses)-Cohort 8ExperimentalZSP0678/Placebo Dose1 will be administrated according to the results of Cohort 2\&3
Receives: Drug: ZSP0678-Dose 1; Drug: ZSP0678 Placebo
ZSP0678 Dose2 (multiple doses)-Cohort 9ExperimentalZSP0678/Placebo Dose2 will be administrated according to the results of Cohort 3\&4
Receives: Drug: ZSP0678-Dose 2; Drug: ZSP0678 Placebo
ZSP0678 Dose3 (multiple doses)-Cohort 10ExperimentalZSP0678/Placebo Dose3 will be administrated according to the results of Cohort 4\&5
Receives: Drug: ZSP0678-Dose 3; Drug: ZSP0678 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and severity of adverse events (AEs) and Serious Adverse Events(SAE) following oral doses of ZSP0678 and placebo.

    Measured: SAD Group: Up to 5 days, MAD: Up to 18 days, FE group: Up to11 days after first dose ]

  2. Tmax

    The time after dosing when Cmax occurs

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  3. Cmax

    Maximum concentration

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  4. t1/2

    t1/2 is defined as the time to decline half of the drug concentration in plasma.

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  5. AUCinf（AUC0-∞）

    Area under the curve extrapolated until time is infinity (AUCinf)

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  6. AUClast（AUC0-t）

    AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  7. CL/F

    CL/F is defined as the ratio of total clearance(Cl) to bioavailability(F).

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  8. λz

    λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound.

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  9. CLr

    CLr is defined as how many milliliters of plasma in which some substance can be completely eliminated in the unit time (per minute) of two kidneys.

    Measured: UP to 5, 18, 11 days for SAD, MAD, FE part respectively

  10. Multiple-dose plasma PK parameter: Rac of ZSP0678 at steady state

    Rac (Accumulation Index) is defined as the ratio between AUC0-XX in Day XX and AUC0-XX in Day1

    Measured: UP to 18 days.

  11. Multiple-dose plasma PK parameter: DF of ZSP0678 at steady state

    DF is defined as the percentage of fluctuation in steady state is 100 * (Cmax, ss - Cmin, ss)/Cavg, ss.

    Measured: UP to 18 days.

  12. Multiple-dose plasma PK parameter: Cmin of ZSP0678 at steady state

    Cmin is defined as the minimum observed concentration of drug in plasma at steady state.

    Measured: UP to 18 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start19 Nov 2019
  3. Primary completion9 Dec 2020
  4. Study completion9 Dec 2020

Resources

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
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04137055
Sponsor's protocol ID
ZSP0678-19-01
Status last verified
Jul 2021
First submitted
15 Oct 2019
Last updated
28 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZSP0678-10mg, ZSP0678-30mg and ZSP0678-60mg in people with Nonalcoholic Steatohepatitis, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.

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 8 inclusion and 19 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 28 Jul 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 China. 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 and severity of adverse events (AEs) and Serious Adverse Events(SAE) following oral doses of ZSP0678 and placebo. (time frame: SAD Group: Up to 5 days, MAD: Up to 18 days, FE group: Up to11 days after first dose ]). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04137055.

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 28 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in