Diopathic Pulmonary Fibrosis, Pulmonary Fibrosis
Conditions
Keywords
Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Lung Diseases, Respiratory Tract Diseases
Brief summary
The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011,in health conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects.Pharmacokinetic profiles in healthy subjects.Food effect in healthy subjects.Participants will complete the study including screening period, dosing period, and observation period. Researchers will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.
Detailed description
This is a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Part B will comprise a multiple-dose, sequential-group study.
Interventions
DRUGSC1011
Each subject in the SAD groups participated in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours post dose).
Sponsors
Guangzhou JOYO Pharma Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females, of any race, between 18 and 45 years of age, inclusive, at Screening. * Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator. * Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception. * Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. * Alcohol consumption of \> 21 units per week for males and \> 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in. * Any screening laboratory or ECG results are not within the normal reference range and are considered clinically significant. * Participants who participated in other clinical trials within 3 months prior to administration. * Blood donation or blood loss exceeding 400 mL within 2 months prior to administration. * Participants who smoked, drank alcohol, tea, food or drink containing xanthine or caffeine, or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion 2 days before drug administration. * Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events related drug. | Evaluations will be conducted for up to 7 days after first administration | Adverse events are coded according to the ICH Medical Dictionary of Regulatory Activities (MedDRA 24.0 or above). ADR: Adverse events that are definitely related, probably related, or undetermined in relation to the investigational drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean of Maximum Observed Plasma Concentration of SC1011 | Evaluations will be conducted for up to 7 days after first administration | Peak concentration. It was directly obtained from the measured data of blood concentration and time. |
| Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011 | Evaluations will be conducted for up to 7 days after first administration | The area under the curve extrapolated from zero to infinity. AUC0-∞=AUC0-t+Ct/λz(Ct is the last determinable blood concentration, λz is elimination rate constant). |
Countries
China
Outcome results
None listed