Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects

A Single-center, Open Label Study to Evaluate the Safety，Tolerability and Pharmacokinetics of Multiple Administration of Sufenidone (SC1011) Tablets in Healthy Adult Volunteers

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Participants will complete the study including screening period, dosing period, and observation period. Investigators 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: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: SC1011; Drug: Placebo tablet

Detailed Description

This is a single-center, open label study to evaluate the safety，tolerability and pharmacokinetics of multiple administration of Sufenidone (SC1011) tablets conducted in 2 groups.

Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was administered once within half an hour after breakfast on day 1, twice daily on days 2-6 and once within half an hour after breakfast on day 7 .

Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was administered for 7 consecutive days, with dosing consisting of one dose within half an hour after breakfast on day 1, twice daily on days 2-6, and once within half an hour after breakfast on day 7.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200020
      • Shanghai Xuhui District Central Hospital

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: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple doses SC1011 300mg（A1）; Drug: SC1011 tablet, SC1011-matching placebo tablet; Treatment: Food intake prior to dosing	Drug: SC1011; SC1011 tablet; Other Names: experimental drug group; Drug: Placebo tablet; SC1011-matching placebo tablet; Other Names: Control Group
Experimental: Multiple doses SC1011 400mg（A2）; Drug: SC1011 tablet; Treatment: Food intake prior to dosing	Drug: SC1011; SC1011 tablet; Other Names: experimental drug group; Drug: Placebo tablet; SC1011-matching placebo tablet; Other Names: Control Group

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.	From baseline to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean of Maximum Observed Plasma Concentration of SC1011	Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011	From baseline to 7 days

Collaborators and Investigators

• Sponsor: Guangzhou JOYO Pharma Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): January 14, 2023
• Study Completion (Actual): January 14, 2023

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: October 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: JYP1011M102

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