Nonalcoholic Steatohepatitis (NASH)Phase 1NCT03392779
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
A Phase 1 study testing ZSP1601 25 mg, ZSP1601 50 mg and ZSP1601 100 mg in people with Nonalcoholic Steatohepatitis (NASH), run by Guangdong Zhongsheng Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 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 (NASH)
- What is being tested?
- ZSP1601 25 mg, ZSP1601 50 mg and ZSP1601 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2018to 22 Mar 2019
- 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 of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects(including partners)have no gestation plans and must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- Males and female subjects between 18-50 years (Both inclusive).
- Body weight is no less than 50kg in males and no less than 45kg in females.Body mass index (BMI) 18≤BMI≤28 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- 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:
- The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
- Known hypersensitivity and/or allergy to some drugs and food.
- Known history of drug or alcohol abuse.(defined as consumption of 14 units of alcohol per week:1 unit=285ml of beer; or the equivalent of 25ml of spirit, or 100ml of wine )
- Subjects who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
- Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
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- History or presence of any disease or condition known to increase the risk of bleeding, eg.acute gastritis, duodenal ulcer, etc.
- Frequently suffers from postural hypotension.
- History of frequent nausea or vomit causes by any etiology.
- Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of CYP3A4 prior to screening or during the study.
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements 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 with recent significant change in diet or exercise .
- Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
- Inability to consume the food provided in the study ( a high fat, high calorie meal includes two eggs for 100g, bacon 20g, a butter toast for 50g, french fries for 115g, whole milk for 240ml).This requirement only applies to subjects under fed condition.
- Presence of clinically significant abnormalities in ECG or QTc>470ms in males,or QTc>480ms 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 or xanthine within 24 hours prior to dosing.
- Take any product contains 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1601 and the Effect of Food on ZSP1601 Pharmacokinetics in Chinese Healthy Subjects.
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 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 ZSP1601 or placebo .
Read the detailed description
The study is a randomized, double-blind phase 1 trial including 3 parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics part.The primary aims of the study as below:
Evaluating the safety and tolerance of single and multiple dose of ZSP1601 in healthy volunteers.
Evaluating the fasting and postprandial pharmacokinetic parameters of ZSP1601 in healthy volunteers.
Eligible participants will be admitted to the trial center on Day -1. Subjects will be randomly assigned to either experimental groups or placebo groups, according to a randomisation schedule in a (4:1) ratio (8 in per experimental group). Subjects in SAD will receive 25、50、100、175、275、350 mg once daily respectively.Each dose will be administrated after assurance of safety for the former dose. Subjects in MAD will receive 50 or 100 mg once daily for 14days respectively.The treatment in food effect consists of 2 periods,and subjects will receive 100mg on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods.To monitor AEs,record abnormalities (12-lead ECG,Vital signs,Physical examination,Clinical Laboratory),and detect the pharmacokinetics of ZSP1601.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- ZSP1601 25 mg, Placebo 25mg, ZSP1601 50 mg, Placebo 50 mg, ZSP1601 100 mg
- 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.
ZSP1601 25 mgDrug
ZSP1601 tablet administered orally once daily under fasted condition
Placebo 25mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
ZSP1601 50 mgDrug
ZSP1601 tablet administered orally once daily under fasted condition
Placebo 50 mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
ZSP1601 100 mgDrug
ZSP1601 tablets administered orally once daily in the fasting state
Placebo 100 mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state
ZSP1601 175 mgDrug
ZSP1601 tablets administerekd orally once daily under fasted condition
Placebo 175 mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
ZSP1601 275 mgDrug
ZSP1601 tablets administered orally once daily in the fasting state
Placebo 275 mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state
ZSP1601 350 mgDrug
ZSP1601 tablets administered orally once daily under fasted condition
Placebo 350mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
ZSP1601 100 mgDrug
ZSP1601 tablets administered orally once daily under fasted or fed condition
Placebo 100mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition
ZSP1601 50 mgDrug
ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
Placebo 50 mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
ZSP1601 100 mgDrug
ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
Placebo 100 mgDrug
Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
| Study group | Role | What they receive |
|---|---|---|
| ZSP1601(single dose)-25 mg while fasted(Cohort 1) | Experimental | ZSP1601 25 mg /Placebo Receives: Drug: ZSP1601 25 mg; Drug: Placebo 25mg |
| ZSP1601(single dose)-50 mg while fasted(Cohort 2) | Experimental | ZSP1601 50 mg/Placebo
Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1. Receives: Drug: ZSP1601 50 mg; Drug: Placebo 50 mg |
| ZSP1601(single dose)-100 mg while fasted(Cohort 3) | Experimental | ZSP1601 100 mg/Placebo
Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2. Receives: Drug: ZSP1601 100 mg; Drug: Placebo 100 mg |
| ZSP1601(single dose)-175 mg while fasted(Cohort 4) | Experimental | ZSP1601 175 mg/Placebo
Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3. Receives: Drug: ZSP1601 175 mg; Drug: Placebo 175 mg |
| ZSP1601(single dose)-275 mg while fasted(Cohort 5,i.e.Group A) | Experimental | ZSP1601 275 mg/Placebo
Enrollment into Cohort 5 will begin upon assurance of safety for Cohort 4. Receives: Drug: ZSP1601 275 mg; Drug: Placebo 275 mg |
| ZSP1601(single dose)-350 mg while fasted(Cohort 6) | Experimental | ZSP1601 350 mg/Placebo
Enrollment into Cohort 6 will begin upon assurance of safety for Cohort 5. Receives: Drug: ZSP1601 350 mg; Drug: Placebo 350mg |
| ZSP1601(food effect)-100 mg (Cohort FE) | Experimental | Period 1 (Day1 to Day4): Group A and Group B receive ZSP1601 100 mg/Placebo under the fasting or fed condition ,respectively on Day1.
Period 2 (Day 8 to Day11): Group A and Group B receive ZSP1601 100 mg/Placebo under the fed or fasting condition ,respectively on Day8. Receives: Drug: ZSP1601 100 mg; Drug: Placebo 100mg |
| ZSP1601(multiple doses)-50 mg (Cohort 7) | Experimental | 50 mg ZSP1601 will be administrated while fasted or fed according to the results of Cohort FE
ZSP1601 50 mg/Placebo for 14 Days. Receives: Drug: ZSP1601 50 mg; Drug: Placebo 50 mg |
| ZSP1601(multiple doses)-100 mg (Cohort 8) | Experimental | Enrollment into Cohort 8 will begin upon assurance of safety for Cohort 7.
ZSP1601 100 mg/Placebo for 14 Days. Receives: Drug: ZSP1601 100 mg; Drug: Placebo 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses(single,multiple and food effect)of ZSP1601 and placebo.
Measured: SAD Group: Up to 4 days, MAD: Up to 17days, FE group: Up to 11 days after first dose
Concomitant Medication
Measured: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Clinical Laboratory Abnormalities(Blood routine test, serum biochemical test, conventional coagulation examinations, urine examination ) post dose of ZSP1601 and placebo.
Measured: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
12-lead ECG Abnormalities following oral dosing of ZSP1601 and placebo.
Measured: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Vital signs Abnormalities following oral dosing of ZSP1601 and placebo.
Measured: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Physical examination Abnormalities following oral dossing of ZSP1601 and placebo.
Measured: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Cardiac color ultrasound(UCG) Abnormalities following multiple oral doses of ZSP1601 and placebo.
Measured: Screening, Day17
Secondary outcomes (13)
AUClast（AUC0-t）of ZSP1601
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Measured: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
AUCinf（AUC0-∞）of ZSP1601
AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Measured: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
Cmax of ZSP1601
Cmax is defined as the maximum observed concentration of drug in plasma.
Measured: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
Tmax of ZSP1601
Tmax is defined as the time to maximum concentration.
Measured: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
t1/2z of ZSP1601
t1/2z is defined as the time to decline half of the drug concentration in plasma.
Measured: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
Single-dose PK Parameter: Ae of ZSP1601
Ae is defined as the amount of unchanged drug excreted in urine or faeces after administration.
Measured: Up to Day 2 post-dose
Single-dose PK Parameter: Fe0-t of ZSP1601
Fe0-t is defined as the cumulative excretion rate of the drug in urine and feces.
Measured: Up to Day 2 post-dose
CL/F of ZSP1601
CL/F is defined as the ratio of total clearance(Cl) to bioavailability(F).
Measured: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
λz of ZSP1601
λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound.
Measured: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
CLr of ZSP1601
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 2, 16, 9 days for SAD, MAD, FE part respectively
Multiple-dose plasma PK parameter: Rac of ZSP1601 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 16days
Multiple-dose plasma PK parameter: DF of ZSP1601 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 16 days
Multiple-dose plasma PK parameter: Cmin of ZSP1601 at steady state
Cmin is defined as the minimum observed concentration of drug in plasma at steady state.
Measured: Up to 16days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start5 Jan 2018
- Primary completion21 Dec 2018
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, MD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392779
- Sponsor's protocol ID
- ZSP1601-16-01
- Status last verified
- Aug 2019
- First submitted
- 2 Jan 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu X, Wu M, Wang H, Li H, Lin J, Peng Y, Hu Y, Li C, Ding Y. Safety, tolerability, and pharmacokinetics of the novel pan-phosphodiesterase inhibitor ZSP1601 in healthy subjects: a double-blinded, placebo-controlled first-in-human single-dose and multiple-dose escalation and food effect study. Expert Opin Investig Drugs. 2021 May;30(5):579-589. doi: 10.1080/13543784.2021.1900822. Epub 2021 Mar 25.
PubMed 33682556
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1601 and the Effect of Food on ZSP1601 Pharmacokinetics in Chinese Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03392779
- Acronym / sponsor ID
- ZSP1601-16-01
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 8 Jan 2018 (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.
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 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 ZSP1601 or placebo .
Detailed description
The study is a randomized, double-blind phase 1 trial including 3 parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics part.The primary aims of the study as below:
Evaluating the safety and tolerance of single and multiple dose of ZSP1601 in healthy volunteers.
Evaluating the fasting and postprandial pharmacokinetic parameters of ZSP1601 in healthy volunteers.
Eligible participants will be admitted to the trial center on Day -1. Subjects will be randomly assigned to either experimental groups or placebo groups, according to a randomisation schedule in a (4:1) ratio (8 in per experimental group). Subjects in SAD will receive 25、50、100、175、275、350 mg once daily respectively.Each dose will be administrated after assurance of safety for the former dose. Subjects in MAD will receive 50 or 100 mg once daily for 14days respectively.The treatment in food effect consists of 2 periods,and subjects will receive 100mg on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods.To monitor AEs,record abnormalities (12-lead ECG,Vital signs,Physical examination,Clinical Laboratory),and detect the pharmacokinetics of ZSP1601.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| ZSP1601(single dose)-25 mg while fasted(Cohort 1) | Experimental | Drug: ZSP1601 25 mg, Drug: Placebo 25mgZSP1601 25 mg /Placebo |
| ZSP1601(single dose)-50 mg while fasted(Cohort 2) | Experimental | Drug: ZSP1601 50 mg, Drug: Placebo 50 mgZSP1601 50 mg/Placebo Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1. |
| ZSP1601(single dose)-100 mg while fasted(Cohort 3) | Experimental | Drug: ZSP1601 100 mg, Drug: Placebo 100 mgZSP1601 100 mg/Placebo Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2. |
| ZSP1601(single dose)-175 mg while fasted(Cohort 4) | Experimental | Drug: ZSP1601 175 mg, Drug: Placebo 175 mgZSP1601 175 mg/Placebo Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3. |
| ZSP1601(single dose)-275 mg while fasted(Cohort 5,i.e.Group A) | Experimental | Drug: ZSP1601 275 mg, Drug: Placebo 275 mgZSP1601 275 mg/Placebo Enrollment into Cohort 5 will begin upon assurance of safety for Cohort 4. |
| ZSP1601(single dose)-350 mg while fasted(Cohort 6) | Experimental | Drug: ZSP1601 350 mg, Drug: Placebo 350mgZSP1601 350 mg/Placebo Enrollment into Cohort 6 will begin upon assurance of safety for Cohort 5. |
| ZSP1601(food effect)-100 mg (Cohort FE) | Experimental | Drug: ZSP1601 100 mg, Drug: Placebo 100mgPeriod 1 (Day1 to Day4): Group A and Group B receive ZSP1601 100 mg/Placebo under the fasting or fed condition ,respectively on Day1. Period 2 (Day 8 to Day11): Group A and Group B receive ZSP1601 100 mg/Placebo under the fed or fasting condition ,respectively on Day8. |
| ZSP1601(multiple doses)-50 mg (Cohort 7) | Experimental | Drug: ZSP1601 50 mg, Drug: Placebo 50 mg50 mg ZSP1601 will be administrated while fasted or fed according to the results of Cohort FE ZSP1601 50 mg/Placebo for 14 Days. |
| ZSP1601(multiple doses)-100 mg (Cohort 8) | Experimental | Drug: ZSP1601 100 mg, Drug: Placebo 100 mgEnrollment into Cohort 8 will begin upon assurance of safety for Cohort 7. ZSP1601 100 mg/Placebo for 14 Days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects are required to meet the following criteria in order to be included in the trial:
Key exclusion criteria (23 listed)
- Eligible subjects must not meet any of the following exclusion criteria:
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 |
|---|---|---|
| ZSP1601 25 mgZSP1601 tablet administered orally once daily under fasted condition | Drug | ZSP1601(single dose)-25 mg while fasted(Cohort 1) |
| Placebo 25mgParticipants will receive placebo matching to ZSP1601 orally once daily under fasted condition | Drug | ZSP1601(single dose)-25 mg while fasted(Cohort 1) |
| ZSP1601 50 mgZSP1601 tablet administered orally once daily under fasted condition | Drug | ZSP1601(single dose)-50 mg while fasted(Cohort 2) |
| Placebo 50 mgParticipants will receive placebo matching to ZSP1601 orally once daily under fasted condition | Drug | ZSP1601(single dose)-50 mg while fasted(Cohort 2) |
| ZSP1601 100 mgZSP1601 tablets administered orally once daily in the fasting state | Drug | ZSP1601(single dose)-100 mg while fasted(Cohort 3) |
| Placebo 100 mgParticipants will receive placebo matching to ZSP1601 orally once daily in the fasting state | Drug | ZSP1601(single dose)-100 mg while fasted(Cohort 3) |
| ZSP1601 175 mgZSP1601 tablets administerekd orally once daily under fasted condition | Drug | ZSP1601(single dose)-175 mg while fasted(Cohort 4) |
| Placebo 175 mgParticipants will receive placebo matching to ZSP1601 orally once daily under fasted condition | Drug | ZSP1601(single dose)-175 mg while fasted(Cohort 4) |
| ZSP1601 275 mgZSP1601 tablets administered orally once daily in the fasting state | Drug | ZSP1601(single dose)-275 mg while fasted(Cohort 5,i.e.Group A) |
| Placebo 275 mgParticipants will receive placebo matching to ZSP1601 orally once daily in the fasting state | Drug | ZSP1601(single dose)-275 mg while fasted(Cohort 5,i.e.Group A) |
| ZSP1601 350 mgZSP1601 tablets administered orally once daily under fasted condition | Drug | ZSP1601(single dose)-350 mg while fasted(Cohort 6) |
| Placebo 350mgParticipants will receive placebo matching to ZSP1601 orally once daily under fasted condition | Drug | ZSP1601(single dose)-350 mg while fasted(Cohort 6) |
| ZSP1601 100 mgZSP1601 tablets administered orally once daily under fasted or fed condition | Drug | ZSP1601(food effect)-100 mg (Cohort FE) |
| Placebo 100mgParticipants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition | Drug | ZSP1601(food effect)-100 mg (Cohort FE) |
| ZSP1601 50 mgZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses). | Drug | ZSP1601(multiple doses)-50 mg (Cohort 7) |
| Placebo 50 mgParticipants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses). | Drug | ZSP1601(multiple doses)-50 mg (Cohort 7) |
| ZSP1601 100 mgZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses). | Drug | ZSP1601(multiple doses)-100 mg (Cohort 8) |
| Placebo 100 mgParticipants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses). | Drug | ZSP1601(multiple doses)-100 mg (Cohort 8) |
Primary outcome
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses(single,multiple and food effect)of ZSP1601 and placebo.
Time frame: SAD Group: Up to 4 days, MAD: Up to 17days, FE group: Up to 11 days after first dose
Concomitant Medication
Time frame: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Clinical Laboratory Abnormalities(Blood routine test, serum biochemical test, conventional coagulation examinations, urine examination ) post dose of ZSP1601 and placebo.
Time frame: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
12-lead ECG Abnormalities following oral dosing of ZSP1601 and placebo.
Time frame: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Vital signs Abnormalities following oral dosing of ZSP1601 and placebo.
Time frame: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Physical examination Abnormalities following oral dossing of ZSP1601 and placebo.
Time frame: UP to 4, 17, 11 days for SAD, MAD, FE part respectively
Cardiac color ultrasound(UCG) Abnormalities following multiple oral doses of ZSP1601 and placebo.
Time frame: Screening, Day17
13 secondary outcomes
AUClast（AUC0-t）of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
AUCinf（AUC0-∞）of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
Cmax of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
Tmax of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
t1/2z of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
Single-dose PK Parameter: Ae of ZSP1601
Time frame: Up to Day 2 post-dose
Single-dose PK Parameter: Fe0-t of ZSP1601
Time frame: Up to Day 2 post-dose
CL/F of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
λz of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
CLr of ZSP1601
Time frame: UP to 2, 16, 9 days for SAD, MAD, FE part respectively
Multiple-dose plasma PK parameter: Rac of ZSP1601 at steady state
Time frame: Up to 16days
Multiple-dose plasma PK parameter: DF of ZSP1601 at steady state
Time frame: Up to 16 days
Multiple-dose plasma PK parameter: Cmin of ZSP1601 at steady state
Time frame: Up to 16days
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 13 Aug 2019.
- Derived from this study: PubMed 33682556Zhu X, Wu M, Wang H, Li H, Lin J, Peng Y, Hu Y, Li C, Ding Y. Safety, tolerability, and pharmacokinetics of the novel pan-phosphodiesterase inhibitor ZSP1601 in healthy subjects: a double-blinded, placebo-controlled first-in-human single-dose and multiple-dose escalation and food effect study. Expert Opin Investig Drugs. 2021 May;30(5):579-589. doi: 10.1080/13543784.2021.1900822. Epub 2021 Mar 25.
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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.
Yanhua Ding, MD principal investigator
The First Hospital of Jilin University
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 ZSP1601 25 mg, ZSP1601 50 mg and ZSP1601 100 mg in people with Nonalcoholic Steatohepatitis (NASH), run by Guangdong Zhongsheng Pharmaceutical 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 23 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 13 Aug 2019. 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 treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses(single,multiple and food effect)of ZSP1601 and placebo. (time frame: SAD Group: Up to 4 days, MAD: Up to 17days, FE group: Up to 11 days after first dose). The study lists 7 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 NCT03392779, which also lists 1 linked publication.
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 13 Aug 2019.