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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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. Extra Criteria for the MAD and Food Effect Parts 7. Healthy female volunteers whose body weight is not less than 45 kg 8. Female subjects show negative pregnancy test results within 30 days prior to the first study dose. 9. Female subjects of child-bearing potential, committing to practicing sexual abstinence or using and continue to use a medically acceptable form of birth control for at least 1 month prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above. Extra Criteria for the MAD Part 10. Subjects who are self-reporting current smokers (>10 pack/years).

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) - Hepatitis C virus (HCV) 8.
Subjects who cannot stop caffeine-intake for 48 hours prior to the first study dose and during the entire study period. 9. Subjects with underlying medical, mental or psychological conditions that would impair treatment compliance, or in the opinion of the investigator would not permit to participate in the study 10. Subjects who have received or are taking any medications that may interfere the assessment [e.g., anti-inflammatories, anti-asthma/COPD (chronic obstructive pulmonary disease) and anti-IPF (idiopathic pulmonary fibrosis) medications] for a period of up to 14 days prior to the first dose of the study Extra Criteria for the MAD and Food Effect Parts 11. Female subjects who are lactating Extra criteria for the MAD part 12. Subjects who did not smoke for more than 2 days prior to the first dose of the study or during the study period

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03650075
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Metagone Biotech Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis (IPF)
Arms & Interventions

Arms

Placebo Comparator: Single Ascending Dose (SAD)

Placebo Comparator: Multiple Ascending Dose (MAD)

Experimental: Food Effect Part

Interventions

Drug: - MG-S-2525

The investigational product is MG-S-2525, which is an oral, small-molecule, anti-inflammatory agent. MG-S-2525 is being developed by Metagone Biotech Inc. and contains the new molecular entity HL0, an inhibitor of MAP3K19 which is up-regulated in disease pathobiology and in response to inflammatory stimuli in IPF.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Taipei Medical University Hospital, Taipei, Taiwan

Status

Recruiting

Address

Taipei Medical University Hospital

Taipei, ,

Site Contact

Feng-Yi Chou

yuyun@metagone.com.tw

02-2737-2181 #3973