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To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers

A Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers

NCT03650075•Metagone Biotech Inc.

View on ClinicalTrials.gov

Summary

This is a Phase I stage to investigate the safety and tolerability of MG-S-2525 in healthy volunteers. The proposed trial consists of 3 study parts to be conducted at Tri-Service General Hospital and includes Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect parts. This study will enroll up to 16 evaluable subjects in the SAD part, 36 evaluable subjects in the MAD part and enroll up to 20 evaluable subjects for the Food Effect part.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Single ascending dose (SAD), Multiple ascending dose (MAD) and Food Effect Parts:
•1. Healthy male volunteers
•2. Subject's age is no less than 20 years old
•3. Subjects whose body mass index (BMI) at screening is within a range of ≥18.5 kg/m2 and \<25.0 kg/m2.
•BMI = Body Weight (kg) / \[Height (m)\]2 Body weight is not less than 50 kg
•4. Subjects who are judged to be in good health by the investigator based upon the results of physical examinations, chest X-ray (within 180 days prior to the first dose of the study) and routine laboratory tests.
•5. Subjects did not take any of the following medications in the specified durations:
•* Any systemically-absorbed medication (excluding vitamins, food supplements, and hormone contraceptives for birth control) within 14 days prior to the first dose of the study
•* Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, troleandomycin, ketoconazole, miconazolem fluconazole, itraconazole) within 30 days prior to the first dose of the study
•6. Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form.
+6 more criteria

Exclusion Criteria

•SAD, MAD and Food Effect Parts:
•1. Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
•2. Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed \>90 days prior to the first dose of the study
•3. Subjects had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.
•4. Subjects had blood donation of more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.
•5. Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria.
•6. Subject's medical history shows contraindications or hypersensitivity to the use of test medications \[HL0 or any component of drug products\].
•7. Subjects who have been tested positive for the following tests:
•* Human immunodeficiency virus (HIV)
•* Hepatitis B virus (HBV)
+6 more criteria

Locations (1)

Taipei Medical University Hospital

Taipei, Taiwan

Key Dates

Start Date

February 25, 2019

Primary Completion Date

December 31, 2019

Completion Date

February 27, 2020

Last Updated

September 2, 2020

Enrollment

ACTUAL participants

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

MG-S-2525

DRUG

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Fibrotic Interstitial Lungs DiseasesIdiopathic Pulmonary Fibrosis (IPF)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Study on the Efficacy of Quercetin Intake in Patients With Fibrotic Interstitial Lung Diseases.

Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis

Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study

Comparison of the Efficacy of Pirfenidone and Nintedanipine in Pulmonary Fibrosis

Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis

Inhaled NAC in Treatment of IPF