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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03650075
• Date of registration: 20/08/2018
• Prospective Registration: Yes
• Primary sponsor: Metagone Biotech Inc.
• Public title: To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers
• Scientific title: A Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers
• Date of first enrolment: February 25, 2019
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03650075
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Taiwan

Key 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis (IPF)

Intervention(s)

Drug: MG-S-2525

Primary Outcome(s)

maximum tolerated dose (MTD) (Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) parts) [Time Frame: approximately 3 weeks (SAD part) or 15 days (MAD part)]

peak concentration (Cmax) under fasting/fed condition (Food Effect Part) [Time Frame: 10 days]

total exposure by area under the curve (AUC) (Food Effect Part) [Time Frame: 10 days]

dose limiting toxicity (DLT) (Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) parts) [Time Frame: approximately 3 weeks (SAD part) or 15 days (MAD part)]

Secondary ID(s)

MEOMGSA20180103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors