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Completed

NCT Number: NCT06160440

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

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.

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Key information

Conditions

Diopathic Pulmonary Fibrosis Fibrosis Idiopathic Interstitial Pneumonias Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Guang Zhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Incidence and severity of adverse events and serious adverse events related drug.

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

    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.

Secondary outcomes

  1. Geometric Mean of Maximum Observed Plasma Concentration of SC1011

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

    Peak concentration. It was directly obtained from the measured data of blood concentration and time.

  2. Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011

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

    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).

Sponsors and collaborators

Lead sponsor

Guangzhou JOYO Pharma Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 7, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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