Clinical trial NCT06160440: The Safety, Tolerability, and Pharmacokinetic Study of SC1011 in Healthy Subjects.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Keywords: Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases
Lead sponsor: Guangzhou JOYO Pharma Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of adverse events and serious adverse events related drug.
timeFrame: Evaluations will be conducted for up to 7 days after first administration
Secondary outcomes:
measure: Geometric Mean of Maximum Observed Plasma Concentration of SC1011
timeFrame: Evaluations will be conducted for up to 7 days after first administration
measure: Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011
timeFrame: Evaluations will be conducted for up to 7 days after first administration
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guang Zhou University of Chinese Medicine
state: Guang Dong
Study officials:
References: