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

Guangzhou JOYO Pharma

Status and phase: Completed; Phase 1

Conditions: Pulmonary Fibrosis; Diopathic Pulmonary Fibrosis

Treatments: Drug: SC1011

Study type: Interventional

Funder types: Industry

Identifiers

NCT06160440

JYE0101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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55 participants in 4 patient groups, including a placebo group

A single dose SC1011 50mg（A1）

Experimental group

Description:

Drug: SC1011 tablet Treatment: No food prior to dosing

Treatment:

Drug: SC1011

A single dose SC1011 150mg（A2）

Placebo Comparator group

Description:

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

Treatment:

Drug: SC1011

A single dose SC1011 150 mg（A3）

Experimental group

Description:

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

Treatment:

Drug: SC1011

A single dose SC1011 300mg（A4）

Experimental group

Description:

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

Treatment:

Drug: SC1011