Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects

NCT06135363 | Completed Phase 1

• 1 other identifier: JYP1011M102
• Study Type: interventional
• Target: 45
• 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 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.

Conditions

Idiopathic 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.

  From baseline to 7 days

Secondary Outcomes (1)

• Geometric Mean of Maximum Observed Plasma Concentration of SC1011

  From baseline to 7 days

Study Arms (2)

Multiple doses SC1011 300mg（A1）

EXPERIMENTAL

Drug: SC1011 tablet, SC1011-matching placebo tablet; Treatment: Food intake prior to dosing

Drug: SC1011; Drug: Placebo tablet

Multiple doses SC1011 400mg（A2）

EXPERIMENTAL

Drug: SC1011 tablet; Treatment: Food intake prior to dosing

Drug: SC1011; Drug: Placebo tablet

Interventions

SC1011 DRUG

SC1011 tablet

Also known as: experimental drug group

Multiple doses SC1011 300mg（A1）; Multiple doses SC1011 400mg（A2）

Placebo tablet DRUG

SC1011-matching placebo tablet

Also known as: Control Group

Multiple doses SC1011 300mg（A1）; Multiple doses SC1011 400mg（A2）

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)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200020, China

Location

MeSH Terms

Conditions

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

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 18, 2023
• Study Start: August 11, 2022
• Primary Completion: January 14, 2023
• Study Completion: January 14, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)