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InfluenzaPhase 1NCT03679143

The Safety, Tolerability and Pharmacokinetic Study of ZSP1273 in Healthy Volunteers.

A Phase 1 study testing ZSP1273 100 mg, ZSP1273 200 mg and ZSP1273 400 mg in people with Influenza, run by Guangdong Zhongsheng Pharmaceutical 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
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Trial summary

This is a single center,double-blind,randomized,parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of ZSP1273,and the effect of food on ZSP1273 Pharmacokinetics. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
ZSP1273 100 mg, ZSP1273 200 mg and ZSP1273 400 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
1 siteChina
Study dates
20 Sep 2018to 26 Apr 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) 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 50 kg in males and no less than 45 kg 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 and vital signs: Normal or abnormality has no clinical significance.

Who cannot join

  • Eligible subjects must not meet any of the following exclusion criteria:
  • Known hypersensitivity and/or allergy to some drugs and food, especially for the composition that is similar to the investigative product;
  • 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 14 units of alcohol per week: 1 unit = 285 ml of beer; or the equivalent of 25 ml of spirit, or 100 ml 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, include a history of frequent nausea or vomit causes by any etiology.
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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.
  • Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, or urticaria.
  • 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.
  • Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents prior to screening or during the study, including strong inhibitory agents and inducers that affect metabolic enzymes (see appendix 6 for specific drug information).
  • 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.
  • Inability to consume the food provided in the study ( a high fat, high calorie meal includes two eggs , a piece of butter bacon toast, a box of fried potatoes, and a glass of whole milk).This requirement only applies to subjects under fed condition.
  • Presence of clinically significant abnormalities in ECG or QTcB>470ms in males, or QTcB>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 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) in the 6 months preceding study screening.
  • Positive hepatitis B surface antigen, hepatitis C virus antibody,human immunodeficiency virus (HIV) or 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.
  • Positive for urine drug screening or history of substance and drug abuse for a period of 5 consecutive years before screening.
  • Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: A Phase 1 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1273 and the Effect of Food on ZSP1273 Pharmacokinetics in Chinese Healthy Subjects.

This is a single center,double-blind,randomized,parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of ZSP1273,and the effect of food on ZSP1273 Pharmacokinetics.

Read the detailed description

The study will be divided in 3 parts :

Study Part I(Single Ascending Dosing, SAD) will be a single ascending dose to be run at a maximum of 6 dose levels. Subjects included in this part of the study will receive only one dose level to limit the exposure to ZSP1273. Four subjects are planned to be included in the first group while 10 subjects are enrolled in every following cohort.

Study Part II(Multiple Ascending Dosing, MAD) will start after completion of some Cohorts of Study Part I. Study Part II will be a multiple ascending dose to be run at a maximum of 3 dose levels. Subjects included in this part of the study will receive only one dose level. This part also enrolls 10 subjects in every cohort.

Study Part III(Food Effect study, FE) will consists of 2 periods,and subjects will receive a single dose ranged from 100-600mg on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods.A total of 12 to 18 subjects will be included.

All the 3 parts will be run in healthy subjects.

Conditions
Influenza
Being tested
ZSP1273 100 mg, Placebo 100 mg, ZSP1273 200 mg, Placebo 200 mg, ZSP1273 400 mg
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZSP1273 100 mgDrug

    ZSP1273 tablet administered orally once daily under fasted condition

  • Placebo 100 mgDrug

    Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state.

  • ZSP1273 200 mgDrug

    ZSP1273 tablets administered orally once daily under fasted condition

  • Placebo 200 mgDrug

    Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition

  • ZSP1273 400 mgDrug

    ZSP1273 tablets administered orally once daily in the fasting state

  • Placebo 400 mgDrug

    Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state

  • ZSP1273 600 mgDrug

    ZSP1273 tablets administered orally once daily under fasted condition

  • Placebo 600 mgDrug

    Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition

  • ZSP1273 900 mgDrug

    ZSP1273 tablets administered orally once daily in the fasting state

  • Placebo 900 mgDrug

    Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition

  • ZSP1273 1200 mgDrug

    ZSP1273 tablets administered orally once daily in the fasting state

  • Placebo 1200 mgDrug

    Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state

  • ZSP1273Drug

    ZSP1273 tablets administered orally once daily under fasted or fed condition

  • PlaceboDrug

    Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition

  • ZSP1273 Low DoseDrug

    ZSP1273 tablets administered orally once daily under fasted or fed condition for 5 Days.

  • PlaceboDrug

    Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition for 5 Days.

  • ZSP1273 Median DoseDrug

    ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.

  • PlaceboDrug

    Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.

  • ZSP1273 High DoseDrug

    ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.

  • PlaceboDrug

    Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.

Study groups in NCT03679143
Study groupRoleWhat they receive
ZSP1273(single dose)-100 mg(Cohort 1)ExperimentalZSP1273 100 mg /Placebo
Receives: Drug: ZSP1273 100 mg; Drug: Placebo 100 mg
ZSP1273(single dose)-200 mg(Cohort 2)ExperimentalZSP1273 200mg/Placebo Enrollment into Cohort 2 will begin upon assurance of tolerance for Cohort 1.
Receives: Drug: ZSP1273 200 mg; Drug: Placebo 200 mg
ZSP1273(single dose)-400 mg(Cohort 3)ExperimentalZSP1273 400mg/Placebo Enrollment into Cohort 3 will begin upon assurance of tolerance for Cohort 2.
Receives: Drug: ZSP1273 400 mg; Drug: Placebo 400 mg
ZSP1273(single dose)-600 mg(Cohort 4)ExperimentalZSP1273 600 mg/Placebo Enrollment into Cohort 4 will begin upon assurance of tolerance for Cohort 3.
Receives: Drug: ZSP1273 600 mg; Drug: Placebo 600 mg
ZSP1273(single dose)-900 mg(Cohort 5)ExperimentalDrug:ZSP1273 900 mg/Placebo 900mg； Enrollment into Cohort 5 will begin upon assurance of tolerance for Cohort 4.
Receives: Drug: ZSP1273 900 mg; Drug: Placebo 900 mg
ZSP1273(single dose)-1200 mg(Cohort 6)ExperimentalZSP1273 1200 mg/Placebo Enrollment into Cohort 6 will begin upon assurance of tolerance for Cohort 5.
Receives: Drug: ZSP1273 1200 mg; Drug: Placebo 1200 mg
ZSP1273(Food Effect)-Cohort 7ExperimentalDrug:ZSP1273 /Placebo； Period 1 (Day1 to Day5): Subjects receive ZSP1273/Placebo under the fasting or fed condition ,respectively on Day1. Period 2 (Day 8 to Day12): Subjects receive ZSP1273/Placebo under the fed or fasting condition, respectively on Day 8.
Receives: Drug: ZSP1273; Drug: Placebo
ZSP1273(multiple doses)-Low Dose(Cohort 8)Experimentalwhile fasted or fed according to the results of Cohort FE ZSP1273 /Placebo for 5 Days.
Receives: Drug: ZSP1273 Low Dose; Drug: Placebo
ZSP1273(multiple doses)-Median Dose(Cohort 9)Experimentalwhile fasted or fed according to the results of Cohort FE ZSP1273/Placebo for 5 Days.
Receives: Drug: ZSP1273 Median Dose; Drug: Placebo
ZSP1273(multiple doses)-High Dose(Cohort 10)Experimentalwhile fasted or fed according to the results of Cohort FE ZSP1273/Placebo for 5 Days.
Receives: Drug: ZSP1273 High Dose; Drug: Placebo

What is being measured

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

  1. Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)

    Number of participants with TEAEs as assessed by CTCAE v5.0.

    Measured: At day 5, 9, 12 days post first dosing for SAD, MAD, FE part respectively

Secondary outcomes (13)

  1. Tmax

    The time after dosing when Cmax occurs (Tmax)

    Measured: UP to 5, 9, 12 days for SAD, MAD, FE part respectively

  2. Cmax

    Maximum concentration (Cmax)

    Measured: UP to 5, 9, 12 days for SAD, MAD, FE part respectively

  3. t1/2z

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

    Measured: UP to 5, 9, 12 days for SAD, MAD, FE part respectively

  4. AUCinf（AUC0-∞）

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

    Measured: UP to 5, 9, 12 days for SAD, MAD, FE part respectively

  5. AUClast（AUC0-t）

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

    Measured: UP to 5, 9, 12 days for SAD, MAD, FE part respectively

  6. CL/F

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

    Measured: UP to 5, 9, 12 days for SAD, MAD, FE part respectively

  7. 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, 9, 12 days for SAD, MAD, FE part respectively

  8. 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, 9, 12 days for SAD, MAD, FE part respectively

  9. Food Effect PK Parameter: Fe0-t

    Fe0-t is defined as the cumulative excretion rate of the drug in urine and feces.

    Measured: UP to 12 days

  10. Food Effect PK Parameter: Ae

    Ae is defined as the amount of unchanged drug excreted in urine or faeces after administration.

    Measured: UP to 12 days

  11. Multiple-dose plasma PK parameter: Rac of ZSP1273 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 9 days

  12. Multiple-dose plasma PK parameter: DF of ZSP1273 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 9 days

  13. Multiple-dose plasma PK parameter: Cmin of ZSP1273 at steady state

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

    Measured: Up to 9 days

Timeline

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

  1. First posted20 Sep 2018
  2. Study start20 Sep 2018
  3. Primary completion19 Mar 2019
  4. Study completion26 Apr 2019

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679143
Sponsor's protocol ID
ZSP1273-18-01
Status last verified
Aug 2019
First submitted
18 Sep 2018
Last updated
14 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hu Y, Li H, Wu M, Zhang H, Ding Y, Peng Y, Li X, Yu Z. Single and multiple dose pharmacokinetics and safety of ZSP1273, an RNA polymerase PB2 protein inhibitor of the influenza A virus: a phase 1 double-blind study in healthy subjects. Expert Opin Investig Drugs. 2021 Nov;30(11):1159-1167. doi: 10.1080/13543784.2021.1994944. Epub 2021 Nov 1.

    PubMed 34654349

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZSP1273 100 mg, ZSP1273 200 mg and ZSP1273 400 mg in people with Influenza, 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 7 inclusion and 22 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 14 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) (time frame: At day 5, 9, 12 days post first dosing for SAD, MAD, FE part respectively). 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 NCT03679143, 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 14 Aug 2019.

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