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Idiopathic Pulmonary Fibrosis(IPF)Phase 1NCT03619616

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults

A Phase 1 study testing ZSP1603 7.5 mg, ZSP1603 12.5 mg and ZSP1603 25 mg in people with Idiopathic Pulmonary Fibrosis(IPF) and Solid Tumor, 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

The Primary objectives of this study are to evaluate the safety and tolerability of ZSP1603 and the Secondary objective is to estimate the pharmacokinetic (PK) parameters after orally administered once daily of ZSP1603. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
ZSP1603 7.5 mg, ZSP1603 12.5 mg and ZSP1603 25 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
16 Jul 2018to 22 Oct 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:
  • 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) 19.0 ≤ BMI ≤ 26.0 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
  • Males or females are without gestation plans or infertility, or females who are menopausal, otherwise must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
  • 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.

Who cannot join

  • Eligible subjects must not meet any of the following exclusion criteria:
  • History or presence of any clinical severe diseases (such as circulatory system, endocrine , neurologic, gastrointestinal, respiratory system, urogenital system, hematic, immune, psychiatric and metabolic abnormalities), or any other diseases that,in the Investigator's opinion,might interfere with the assessment or follow-up;
  • Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to the investigative product;
  • Subjects who have received a surgery within 4 weeks prior to the test or who plan to perform a surgery during the study;
  • Use of any drugs or health care products (including herbs) within 14 days prior to screening.
  • Any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of CYP3A4 within 30 days prior to dosing (such as inducer - Barbituric , Carmazepin , Phenyltoin , Glucocorticoids , and Omeprazole ; Inhibitors - SSRI antidepressants , Cimitedin , Diltiazem , Macrolides , Nitroimidazoles , Sedative hypnotic , Verapamil , Fluoroquinolone , Anti - histamine ).
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  • Participated in another clinical research study and received any other investigational products within 3 months prior to dosing.
  • Subjects who donated blood or bleeding profusely(≥ 200 mL), received blood transfusion or use of blood products in the 3 months preceding study screening.
  • Pregnancy or breastfeeding at screening and during the study. All female subjects of childbearing potential and their partners cannot use at least one reliable method of non-drug contraception during the study and until 6 months following the last dose of investigational product.
  • Subjects who have special dietary habit and inability to consume the food provided in the study;
  • Subjects who could not tolerate venipuncture;
  • Dysphagia of capsule;
  • Frequently drinks tea, coffee and/or caffeinated beverages(more than 8 cups, 1 cup =250 mL) per day ;
  • Daily consuming more than 5 cigarettes within 3 months prior to screening or cannot stop using any tobacco products during the trial.
  • Smoke or have grapefruit juice,any food or beverage that contains alcohol or xanthin (including chocolate, tea, coffee, cola, etc.) from 48 hours pre-dose to the last blood collection ;
  • Known history of alcohol abuse (defined as consumption of more than 14 units of alcohol per week: 1 unit=360 ml of beer,or the equivalent of 45 mL liquor with 40% alcohol content, or 150 ml of wine;)or take any product contains alcohol during the study.
  • Known history of drug abuse or subjects who have used soft drugs (e.g., marijuana) within 3 months prior to screening, or have taken hard drugs (such as cocaine, phencyclidine, etc.) within one year before screening.
  • Presence clinically significant abnormalities (based on the judgment of clinical research doctors) of vital signs (systolic pressure <90 mmHg or >140 mmHg; diastolic pressure <60 mmHg or >90 mmHg；HR <50 bpm or>100 bpm) or ECG (QTcB>450ms in males, or QTcB>480ms in females) or physical examination, clinical laboratory tests and imaging examination.
  • 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 Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

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 ZSP1603 in Chinese Healthy Subjects

The Primary objectives of this study are to evaluate the safety and tolerability of ZSP1603 and the Secondary objective is to estimate the pharmacokinetic (PK) parameters after orally administered once daily of ZSP1603.

Read the detailed description

This is a Phase 1, double-blinded, placebo-controlled, single center study aimed at investigating the safety, tolerability and the pharmacokinetics of ZSP1603 on fasted condition.Up to 4 cohorts of 32 eligible participants totally are planned to be enrolled. This is a two-arm clinical trial that ZSP1603 and matching placebo will be orally administered once daily. Two subjects in the first cohort will be assigned in a opened fashion to receive 7.5mg of ZSP1603 while another three cohorts of volunteers will be randomly assigned in a blinded fashion to receive either a single dose of ZSP1603 or matching placebo in an ascending dose fashion. To monitor AEs,record abnormalities (Holter, 12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of ZSP1603.

Being tested
ZSP1603 7.5 mg, ZSP1603 12.5 mg, Placebo 12.5mg, ZSP1603 25 mg, Placebo 25mg
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

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

  • ZSP1603 7.5 mgDrug

    ZSP1603 capsule administered orally once daily under fasted condition.

  • ZSP1603 12.5 mgDrug

    ZSP1603 capsule administered orally once daily in the fasting state.

  • Placebo 12.5mgDrug

    Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.

  • ZSP1603 25 mgDrug

    ZSP1603 capsule administered orally once daily under fasted condition.

  • Placebo 25mgDrug

    Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.

  • ZSP1603 50 mgDrug

    ZSP1603 capsule administered orally once daily under fasted state.

  • Placebo 50mgDrug

    Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.

Study groups in NCT03619616
Study groupRoleWhat they receive
ZSP1603 (single dose)-7.5 mg (Cohort 1)ExperimentalSubject adminsitered at a dose of ZSP1603 7.5 mg on day 1 under fasted condition.
Receives: Drug: ZSP1603 7.5 mg
ZSP1603 (single dose)-12.5mg (Cohort 2)ExperimentalSubject adminsitered at a dose of ZSP1603 12.5 mg or placebo on day 1 under fasted condition. Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1.
Receives: Drug: ZSP1603 12.5 mg; Drug: Placebo 12.5mg
ZSP1603 (single dose)-25 mg (Cohort 3)ExperimentalSubject adminsitered at a dose of ZSP1603 25 mg or placebo on day 1 under fasted condition. Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2.
Receives: Drug: ZSP1603 25 mg; Drug: Placebo 25mg
ZSP1603 (single dose)-50 mg (Cohort 4)ExperimentalSubject adminsitered at a dose of ZSP1603 50 mg or placebo on day 1 under fasted condition. Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3.
Receives: Drug: ZSP1603 50 mg; Drug: Placebo 50mg

What is being measured

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

  1. Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately.

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

    Measured: At Day 6 post-dose.

Secondary outcomes (9)

  1. AUClast（AUC0-t）of ZSP1603

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

    Measured: Up to 6 days post-dose

  2. AUC0-24 of ZSP1603

    AUC0-24 is defined as the concentration of drug from zero(0) hrs to 24h (area under the plasma concentration versus time curve from zero(0) hrs to 24h).

    Measured: Up to 6 days post-dose

  3. Cmax of ZSP1603

    Cmax is defined as the maximum observed concentration of drug in plasma.

    Measured: Up to 6 days post-dose

  4. Tmax of ZSP1603

    Tmax is defined as the time to maximum concentration.

    Measured: Up to 6 days post-dose

  5. t1/2 of ZSP1603

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

    Measured: Up to 6 days post-dose

  6. CL/F of ZSP1603

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

    Measured: Up to 6 days post-dose

  7. λz of ZSP1603

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

    Measured: Up to 6 days post-dose

  8. VD/F of ZSP1603

    VD/F is defined as apparent volume of distribution

    Measured: Up to 6 days post-dose

  9. MRT of ZSP1603

    MRT is defined as mean residence time

    Measured: Up to 6 days post-dose

Timeline

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

  1. First posted8 Aug 2018
  2. Study start16 Jul 2018
  3. Primary completion28 Jun 2019
  4. Study completion22 Oct 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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03619616
Sponsor's protocol ID
XY3-PK-ZSP1603
Status last verified
Oct 2019
First submitted
23 Jul 2018
Last updated
23 Oct 2019
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 ZSP1603 7.5 mg, ZSP1603 12.5 mg and ZSP1603 25 mg in people with Idiopathic Pulmonary Fibrosis(IPF) and Solid Tumor, 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 6 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 23 Oct 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 of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately. (time frame: At Day 6 post-dose.). 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 NCT03619616.

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 23 Oct 2019.

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