The Safety, Tolerability, and Pharmacokinetic Study of SC1011 in Healthy Subjects.

A Phase I, Single-center, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Tolerability, Pharmacokinetic, and Food Effect Study of SC1011 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis; Diopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: SC1011

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510000
      • First Affiliated Hospital of Guang Zhou University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A single dose SC1011 50mg（A1）; Drug: SC1011 tablet Treatment: No food prior to dosing	Drug: SC1011; 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).
Placebo Comparator: A single dose SC1011 150mg（A2）; Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing	Drug: SC1011; 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).
Experimental: A single dose SC1011 150 mg（A3）; Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing	Drug: SC1011; 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).
Experimental: A single dose SC1011 300mg（A4）; Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing	Drug: SC1011; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events and serious adverse events related drug.	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.	Evaluations will be conducted for up to 7 days after first administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean of Maximum Observed Plasma Concentration of SC1011	Peak concentration. It was directly obtained from the measured data of blood concentration and time.	Evaluations will be conducted for up to 7 days after first administration
Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011	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).	Evaluations will be conducted for up to 7 days after first administration

Collaborators and Investigators

• Sponsor: Guangzhou JOYO Pharma Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Lung Diseases; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: JYE0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No