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

NCT06160440 | Completed Phase 1

• 1 other identifier: JYE0101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Diopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Keywords

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Geometric Mean of Maximum Observed Plasma Concentration of SC1011

  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

  Evaluations will be conducted for up to 7 days after first administration

Study Arms (4)

A single dose SC1011 50mg（A1）

EXPERIMENTAL

Drug: SC1011 tablet Treatment: No food prior to dosing

Drug: SC1011

A single dose SC1011 150mg（A2）

PLACEBO COMPARATOR

Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing

Drug: SC1011

A single dose SC1011 150 mg（A3）

EXPERIMENTAL

Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing

Drug: SC1011

A single dose SC1011 300mg（A4）

EXPERIMENTAL

Drug: SC1011 tablet Drug: SC1011-matching placebo tablet Treatment: No food prior to dosing

Drug: SC1011

Interventions

SC1011 DRUG

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).

A single dose SC1011 150 mg（A3）; A single dose SC1011 150mg（A2）; A single dose SC1011 300mg（A4）; A single dose SC1011 50mg（A1）

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

First Affiliated Hospital of Guang Zhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Idiopathic Interstitial Pneumonias; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: December 7, 2023
• Study Start: June 3, 2021
• Primary Completion: September 23, 2021
• Study Completion: February 23, 2022
• Last Updated: November 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)