Study on the Bioavailability of SHR0302 in Healthy Subjects

NCT04712838 | Completed Phase 1

• 1 other identifier: SHR0302-108
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, and the relative bioavailability of SHR0302 tablets with three different formulations in healthy subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• The peak plasma concentration (Cmax) of SHR0302.

  Based on the PK concentration data set, calculate the peak plasma concentration of SHR0302 by non-compartmental analysis.

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.

• Area Under the Plasma Concentration Versus Time Curve (AUC) of SHR0302.

  Based on the SHR0302 plasma concentration data set, calculate the Area Under the Plasma Concentration Versus Time Curve of SHR0302 by non-compartmental analysis.

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.

• The relative bioavailability of SHR0302 tablets with 3 different formulations.

  The mixed effect model is used to estimate the least square mean difference and 90% confidence interval between different formulations, and then take the antilog to obtain the estimate of the ratio of the least square geometric mean of the corresponding PK parameter and the 90% confidence interval Time.

  through study completion, an average of 1 month.

Secondary Outcomes (5)

• The Peak Time (Tmax) of SHR0302.

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.

• The Elimination half-life (T1/2) of SHR0302.

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.

• The Clearance (CL/F) of SHR0302.

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.

• The apparent volume of distribution (Vz/F) of SHR0302.

  0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.

• Incidence of adverse events.

  through study completion, an average of 1 month

Study Arms (6)

group A

EXPERIMENTAL

Drug: SHR0302

group B

EXPERIMENTAL

Drug: SHR0302

group C

EXPERIMENTAL

Drug: SHR0302

group D

EXPERIMENTAL

Drug: SHR0302

group E

EXPERIMENTAL

Drug: SHR0302

group F

EXPERIMENTAL

Drug: SHR0302

Interventions

SHR0302 DRUG

Group A subjects were given oral F1 、F2 and F3 version SHR0302

group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer to sign an informed consent form before the start of the relevant activities of this trial, understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial
• \~45 years old (including both ends, subject to when signing the informed consent form), healthy male
• Weight ≥ 50 kg, and body mass index (BMI): 19\~26 kg/m2 (including both ends)
• Those who have signed the informed consent and have no birth plan within 6 months after the last administration, and agree to take effective contraceptive measures
• Able to communicate well with the researcher, and understand and comply with the requirements of this research

You may not qualify if:

• Suspected of being allergic to the study drug or any ingredient in the study drug, or allergic
• Those who have participated in clinical trials of any drugs and medical devices within six months before screening (subject to the signed informed consent form)
• Subjects with any systemic inflammatory disease or autoimmune disease
• Subjects with a history of recurrent herpes zoster, disseminated herpes zoster or disseminated herpes simplex
• Subjects with a history of malignant tumors
• Subjects with mental or neurological diseases, unwilling to communicate or have language barriers, unable to fully understand and cooperate
• Those who have a history of tuberculosis (TB) within six months before screening, or have clinical or imaging evidence of active or occult TB
• Routine blood examination during the screening period: white blood cell count \<3.0×109/L and/or neutrophil count \<1.5×109/L
• Subjects Those with serum creatinine\> 1.5 mg/dL (133 μmol/L) at the time of screening
• At the time of screening, 12-ECG check QTcF\>450 ms or there are other abnormal conditions judged by the investigator to be clinically meaningful
• Those who are positive for hepatitis B surface antigen, hepatitis C antibodies, syphilis antibodies, and HIV antibodies
• Those who smoked more than 5 cigarettes daily in the 3 months before screening and cannot stop using any Tobacco products
• Those who drink regularly in the 6 months before screening, drink more than 14 units of alcohol per week (1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine) and cannot stop using any alcoholic products during the trial; those who have a positive alcohol breath test
• People who have a history of drug abuse, drug dependence or a positive urine drug abuse screening before administration, including: morphine, methamphetamine (methamphetamine), ketamine, cocaine, ecstasy (dimethylene) Dioxyamphetamine), cannabis (tetrahydrocannabinolic acid)
• Those who have had any surgery within 6 months before screening

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital Beijing,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Interventions

ivarmacitinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The relative bioavailability of SHR0302 tablets with three different formulations

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: March 15, 2021
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

CN (1)