Idiopathic Pulmonary Fibrosis (IPF)Phase 1NCT03650075
To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers
A Phase 1 study testing MG-S-2525 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Metagone Biotech Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- MG-S-2525
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Feb 2019to 27 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single ascending dose (SAD), Multiple ascending dose (MAD) and Food Effect Parts:
- Healthy male volunteers
- Subject's age is no less than 20 years old
- 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
- 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.
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- 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
- 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
- Healthy female volunteers whose body weight is not less than 45 kg
- Female subjects show negative pregnancy test results within 30 days prior to the first study dose.
- 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
- Subjects who are self-reporting current smokers (>10 pack/years).
Who cannot join
- SAD, MAD and Food Effect Parts:
- Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
- 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
- Subjects had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.
- 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.
- 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.
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- Subject's medical history shows contraindications or hypersensitivity to the use of test medications [HL0 or any component of drug products].
- Subjects who have been tested positive for the following tests:
- Human immunodeficiency virus (HIV)
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Subjects who cannot stop caffeine-intake for 48 hours prior to the first study dose and during the entire study period.
- 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
- 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
- Female subjects who are lactating Extra criteria for the MAD part
- Subjects who did not smoke for more than 2 days prior to the first dose of the study or during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers
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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- MG-S-2525
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG-S-2525Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) | Placebo comparator | Not described Receives: Drug: MG-S-2525 |
| Multiple Ascending Dose (MAD) | Placebo comparator | Not described Receives: Drug: MG-S-2525 |
| Food Effect Part | Experimental | Not described Receives: Drug: MG-S-2525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose (MTD) (Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) parts)
MTD will be determined by study definition
Measured: approximately 3 weeks (SAD part) or 15 days (MAD part)
dose limiting toxicity (DLT) (Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) parts)
Number of subjects with DLT will be presented by dose group.
Measured: approximately 3 weeks (SAD part) or 15 days (MAD part)
total exposure by area under the curve (AUC) (Food Effect Part)
The 90% confidence intervals for geometric mean ratios of Cmax will be estimated and presented by gender.
Measured: 10 days
peak concentration (Cmax) under fasting/fed condition (Food Effect Part)
The 90% confidence intervals for geometric mean ratios of AUC0→inf will be estimated and presented by gender.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start25 Feb 2019
- Primary completion31 Dec 2019
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagone Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650075
- Sponsor's protocol ID
- MEOMGSA20180103
- Status last verified
- Sep 2020
- First submitted
- 20 Aug 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03650075
- Acronym / sponsor ID
- MEOMGSA20180103
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Metagone Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Placebo comparator | Drug: MG-S-2525 |
| Multiple Ascending Dose (MAD) | Placebo comparator | Drug: MG-S-2525 |
| Food Effect Part | Experimental | Drug: MG-S-2525 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy male volunteers
- Subject's age is no less than 20 years old
- 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
- 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.
Key exclusion criteria (16 listed)
- Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
- 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
- Subjects had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG-S-2525The 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. | Drug | Food Effect Part, Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
Primary outcome
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)
MTD will be determined by study definition
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)
Number of subjects with DLT will be presented by dose group.
total exposure by area under the curve (AUC) (Food Effect Part)
Time frame: 10 days
The 90% confidence intervals for geometric mean ratios of Cmax will be estimated and presented by gender.
peak concentration (Cmax) under fasting/fed condition (Food Effect Part)
Time frame: 10 days
The 90% confidence intervals for geometric mean ratios of AUC0→inf will be estimated and presented by gender.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MG-S-2525 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Metagone Biotech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.