SarcopeniaPhase 2NCT05283486
Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty
A Phase 2 study testing MYMD-1 600MG, MYMD-1 750mg and MYMD-1 900mg in people with Sarcopenia and Frailty, run by TNF Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Sarcopenia, Frailty, Aging
- What is being tested?
- MYMD-1 600MG, MYMD-1 750mg and MYMD-1 900mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2022to 7 Jun 2023
- Phase
- Phase 2
- 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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older, at the time of signing the ICF
- Type of Participant and Disease Characteristics
- Elevated biomarkers of inflammation (serum IL-6 level ≥2.5 pg/mL and/or sTNFR1 level ≥1500 pg/mL)
- Low gait speed ≤ 0.8 m/s
- Short Physical Performance Battery (SPPB) score ≤8
- Weight
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- Body weight ≥35 kg Other
- Adequate dietary intake
- Able to complete a 4-meter timed walk
- Assessment and documentation of sarcopenia-related loss of muscle mass based on Dual-energy X-ray absorptiometry (DXA) -derived appendicular skeletal muscle mass index (ASMI) measurements.
- Reproductive Status
- Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP)
- Informed Consent
- Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Who cannot join
- Taking anti-inflammatory drugs on a daily basis. Note: If the participant has been stable on their antidepressant regimen for at least 3 months and agrees not to increase the medicine for the 28 days of treatment in the trial, they may be allowed into the study
- Currently tobacco users or those who used tobacco within 30 days of study entry
- Dementia, encephalopathy or any medical condition impacting cognition
- Medical conditions that would impact mobility testing or handgrip strength including
- Rheumatoid arthritis, any autoimmune condition, Parkinson's disease, muscular dystrophy, cerebral vascular accident, lower or upper extremity neuropathy, major skeletal joint deformity, upper extremity joint dysfunction, partial or complete upper extremity amputation or missing anatomy impacting grip, history of pain with walking, gout, chronic obstructive pulmonary disease, congestive heart failure, exercise induced angina, lower extremity amputation (partial or complete) or missing anatomy impacting walking, recent surgery or hospitalization (past 3 months); lower or upper extremity fracture in the past 6 months, lower or upper extremity tendinitis, diagnosis of cancer other than basal cell carcinoma, dialysis dependent renal disease, Meniere's disease, spinal cord fracture or compression, paraplegia or quadriplegia or any other medical condition that in the opinion of the Investigator would impair measurement of a 6-minute walk or handgrip strength
- A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (eg, stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management)
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- Requires regular assistance from another person for general activities of daily living (eg, bathing, dressing, toileting)
- History of cardiac conduction abnormalities, arrhythmias, and/or bradycardia
- Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening
- Any underlying muscle disease including active myopathy or muscular dystrophy
- Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (eg, dilated cardiomyopathy)
- Type I diabetes or uncontrolled Type 2 diabetes
- Chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min)
- History of confirmed chronic obstructive pulmonary disease with a severity Grade >2 on the Medical Research Council Dyspnea Scale
- Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/day prednisone equivalent
- Known history or presence of severe active acute or chronic liver disease (eg, cirrhosis)
- Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (eg, angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening
- Active cancer (ie, under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (eg, early-stage prostate or breast cancer, carcinoma in situ of the uterine cervix)
- Any known chronic active infection
- Use of any anxiolytics, cannabis or opioid medications
- Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study
- A score of <23 on the Mini Mental Status Exam
- Treatment with any prescription or investigational drugs, devices or chemotherapy, or any other therapies for sarcopenia
- Use of medications with narrow therapeutic ranges within 48 hours of the first dose of study treatment
- Current use of systemic steroids or use of systemic steroids within 90 days of treatment except for prophylaxis against imaging contrast dye allergy or replacement-dose steroids in the setting of adrenal insufficiency (providing this is ≤10 mg/day prednisone or equivalent; see Appendix 5 for steroid conversion table), or transient exacerbations of other underlying diseases such as chronic obstructive pulmonary disease requiring treatment for <3 weeks
- Vaccination with live vaccines while on study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Clinical Research of West Florida, Inc
Clearwater, Florida, 33765
Clinical Research of West Florida
Tampa, Florida, 33606
About this study
Official title: A Double-blind, Randomized, Phase 2 Study to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD1 in the Treatment of Participants Aged 65 Years or Older With Chronic Inflammation Associated With Sarcopenia/Frailty
The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines.
Read the detailed description
This is a double-blind, placebo-controlled evaluation of the efficacy, tolerability and pharmacokinetics (PK), of MYMD1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty. After participants sign the informed consent form (ICF), they will enter the screening period which will not exceed 28 days. Participants who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized (4:1) to receive MYMD1 or placebo in a blinded fashion until the end of-study (EOS) visit on Day 28. A participant is considered to have completed the study if he/she has completed all phases of the study including the EOS visit scheduled on Day 28.
Follow up: Participants will be contacted within 24 hours post Day 1 treatment for routine medical assessment. Participants will be contacted by phone every two days post discharge until day 7 visit. Week two post discharge participants will be instructed to call the Clinical nurse and/or the 24-hour medical monitor for any study related concerns. After the EOS visit, participants will be contacted by phone weekly for a completed 30 day follow up and documented close out.
Study treatment will be dispensed on Day 1 of each cohort. Cohort 1 will be required to take 600mg [4 capsules of 150 mg each or matching placebo]; Cohort 2 will be required to take 750mg ([5 capsules of 150 mg each or matching placebo]; Cohort 3 will be required to take 900mg ([6 capsules of 150 mg each or matching placebo]; and Cohort 4 will be required to take 1050mg ([7 capsules of 150 mg each or matching placebo] orally each orally each day throughout the treatment duration.
On Day 1, a single, oral dose of MYMD1 or placebo will be administered following an overnight fast of at least 12 hours. The participants may have applesauce, 15 to 20 minutes post dose.
Number of Investigators and Study Centers:
Approximately 2 sites are expected to participate in this study.
Number of Participants:
Approximately 40 participants will be enrolled in this study; 32 participants will receive the study treatment (MYMD1) and 8 will receive the placebo.
Treatment Groups and Duration:
The overall duration for all participants enrolled in this study will be 28 days. Serial PK sampling will be collected across all cohorts.
Statistical methods:
Incidence of adverse events will be summarized by dose level, by preferred term, and by severity and relationship to the study treatment.
Descriptive statistics will be tabulated for clinical laboratory tests, electrocardiogram intervals, and vital signs.
MYMD1 concentrations and calculated PK parameters will be summarized by dose level and study data. Dose proportionality of MYMD1 will be explored graphically, and if appropriate, by using a regression model.
Pyridyloxobutyl and tumor necrosis factor-α results and corresponding changes from baseline will be summarized by dose level.
Individual participant data will be presented in listings.
For change from baseline efficacy analyses, only participants with a baseline and at least one non missing postbaseline measurement will be included.
Treatment emergent Adverse Eventss (TEAEs) by maximum severity, TEAEs by relationship to study treatment, Serious Adverse Events, TEAEs leading to death, and TEAEs leading to discontinuation of study treatment will be tabulated for each treatment group. Commonly occurring TEAEs in either treatment group, will be summarized using descriptive statistics.
All laboratory test results, vital signs measurements, electrocardiogram (ECG) results, and weight will be summarized for each treatment group using descriptive statistics at each visit for raw numbers and change from baseline. The incidence of treatment emergent abnormal laboratory values, vital signs, neurological exam and ECG values will also be summarized using descriptive statistics.
Safety Review Committee A Safety Review Committee (SRC) consisting of the Investigator, Medical Monitor, and PK Scientist will review the available PK safety data to decide whether to escalate to the next higher planned dose, to repeat a dose level or to stop the dose escalation. To maintain the treatment assignment blinded, safety data will exclude treatment assignment and PK data will have blinded participant identification numbers. All SRC decisions, along with their rationale, will be documented in writing, and retained in the study files.
The data review and analysis will be based on the available Investigator-reported data in the clinical database at that time. Data to be reviewed will include safety, tolerability, and available PK data through day 8.
The Coordinating Investigator and the Sponsor, when appropriate, will invite other specialist individuals to participate in the review, eg, PK scientists, statisticians, and clinical specialists. MyMD Pharmaceuticals, Inc. will also have a board-certified cardiologist and neurologist available for consultation.
- Conditions
- Sarcopenia, Frailty, Aging
- Being tested
- MYMD-1 600MG, MYMD-1 750mg, MYMD-1 900mg, MYMD-1 1050mg, placebo 600mg
- Keywords
- frailty, aging, sarcopenia
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYMD-1 600MGDrug
Also called MYMD1 600mg
Cohort 1: 600mg drug
MYMD-1 750mgDrug
Also called MYMD1 750mg
Cohort 2: 750mg drug
MYMD-1 900mgDrug
Also called MYMD1 900mg
Cohort 3: 900mg drug
MYMD-1 1050mgDrug
Also called MYMD1 1050mg
Cohort 4: 1050mg drug
placebo 600mgDrug
Also called placebo-600mg
Cohort 1: 600mg placebo
placebo 750mgDrug
Also called placebo-750mg
Cohort 2: 750mg placebo
placebo 900mgDrug
Also called placebo-900mg
Cohort 3: 900mg placebo
placebo 1050mgDrug
Also called placebo-1050mg
Cohort 4: 1050mg placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: MYMD1 600mg | Experimental | Subjects randomly assigned to the MYMD1 600mg cohort Receives: Drug: MYMD-1 600MG |
| Cohort 1: Placebo 600mg | Placebo comparator | Subjects assigned to the 600mg placebo group Receives: Drug: placebo 600mg |
| Cohort 2: MYMD1 750mg | Experimental | Subjects randomly assigned to the MYMD1 750 cohort Receives: Drug: MYMD-1 750mg |
| Cohort 2: Placebo 750mg | Placebo comparator | Subjects assigned to the 750mg placebo group Receives: Drug: placebo 750mg |
| Cohort 3: MYMD1 900mg | Experimental | Subjects randomly assigned to the MYMD1 900mg cohort Receives: Drug: MYMD-1 900mg |
| Cohort 3: Placebo 900mg | Placebo comparator | Subjects assigned to the 900mg placebo group Receives: Drug: placebo 900mg |
| Cohort 4: MYMD1 1050mg | Active comparator | Subjects randomly assigned to the MYMD1 1050mg cohort Receives: Drug: MYMD-1 1050mg |
| Cohort 4: Placebo group 1050mg | Placebo comparator | Subjects assigned to the 1050mg placebo group Receives: Drug: placebo 1050mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Measured: Screening
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Measured: Day 1
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Measured: Day 7
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Measured: Day 14
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Measured: Day 21
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Measured: Day 28
To evaluate the PK of oral doses of MYMD1 capsules
Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time, compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: Cmax - Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokintetics: tmax - Time to Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: t1/2 - Time to metabolize 1/2 of dose (eg, half-life) of drug substance, measured in blood plasma, compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: CL/F - Oral Clearance of the drug substance (CL/F), compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: Volume of Distribution (V2/F ) - Volume of Distribution of the drug substance (V2/F), compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 1 (predose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 1 (0-4 hrs post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 1 (4-8 hrs post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 1(8-24hrs post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 7 (predose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 7 (0-4 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 7 (4-8 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 7 (8-24hrs post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 14 (predose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 14 (0-4 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 14 (4-8 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 14 (8-24 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 21 (predose)
To evaluate the PK of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 21 (0-4 hrs post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 21 (4-8 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 21 (8-24 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 28 (pre dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 28 (0-4hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 28 (4-8 hours post dose)
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
Measured: Day 28 (8-24 hours post dose)
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Feb 2022
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNF Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonard Dunn, MD, Principal investigator, Clinical Research of West FloridaLon Lynn, DO, Principal investigator, Clinical Research of West FloridaJeremy Walston, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283486
- Sponsor's protocol ID
- MyMD-PK-003
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2022
- Last updated
- 30 Oct 2023
- 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Phase 2 Study to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD1 in the Treatment of Participants Aged 65 Years or Older With Chronic Inflammation Associated With Sarcopenia/Frailty
- ClinicalTrials.gov ID
- NCT05283486
- Acronym / sponsor ID
- MyMD-PK-003
- Conditions
- Sarcopenia, Frailty, Aging
- Keywords
- frailty, aging, sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TNF Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 17 Mar 2022 (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.
The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines.
Detailed description
This is a double-blind, placebo-controlled evaluation of the efficacy, tolerability and pharmacokinetics (PK), of MYMD1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty. After participants sign the informed consent form (ICF), they will enter the screening period which will not exceed 28 days. Participants who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized (4:1) to receive MYMD1 or placebo in a blinded fashion until the end of-study (EOS) visit on Day 28. A participant is considered to have completed the study if he/she has completed all phases of the study including the EOS visit scheduled on Day 28.
Follow up: Participants will be contacted within 24 hours post Day 1 treatment for routine medical assessment. Participants will be contacted by phone every two days post discharge until day 7 visit. Week two post discharge participants will be instructed to call the Clinical nurse and/or the 24-hour medical monitor for any study related concerns. After the EOS visit, participants will be contacted by phone weekly for a completed 30 day follow up and documented close out.
Study treatment will be dispensed on Day 1 of each cohort. Cohort 1 will be required to take 600mg [4 capsules of 150 mg each or matching placebo]; Cohort 2 will be required to take 750mg ([5 capsules of 150 mg each or matching placebo]; Cohort 3 will be required to take 900mg ([6 capsules of 150 mg each or matching placebo]; and Cohort 4 will be required to take 1050mg ([7 capsules of 150 mg each or matching placebo] orally each orally each day throughout the treatment duration.
On Day 1, a single, oral dose of MYMD1 or placebo will be administered following an overnight fast of at least 12 hours. The participants may have applesauce, 15 to 20 minutes post dose.
Number of Investigators and Study Centers:
Approximately 2 sites are expected to participate in this study.
Number of Participants:
Approximately 40 participants will be enrolled in this study; 32 participants will receive the study treatment (MYMD1) and 8 will receive the placebo.
Treatment Groups and Duration:
The overall duration for all participants enrolled in this study will be 28 days. Serial PK sampling will be collected across all cohorts.
Statistical methods:
Incidence of adverse events will be summarized by dose level, by preferred term, and by severity and relationship to the study treatment.
Descriptive statistics will be tabulated for clinical laboratory tests, electrocardiogram intervals, and vital signs.
MYMD1 concentrations and calculated PK parameters will be summarized by dose level and study data. Dose proportionality of MYMD1 will be explored graphically, and if appropriate, by using a regression model.
Pyridyloxobutyl and tumor necrosis factor-α results and corresponding changes from baseline will be summarized by dose level.
Individual participant data will be presented in listings.
For change from baseline efficacy analyses, only participants with a baseline and at least one non missing postbaseline measurement will be included.
Treatment emergent Adverse Eventss (TEAEs) by maximum severity, TEAEs by relationship to study treatment, Serious Adverse Events, TEAEs leading to death, and TEAEs leading to discontinuation of study treatment will be tabulated for each treatment group. Commonly occurring TEAEs in either treatment group, will be summarized using descriptive statistics.
All laboratory test results, vital signs measurements, electrocardiogram (ECG) results, and weight will be summarized for each treatment group using descriptive statistics at each visit for raw numbers and change from baseline. The incidence of treatment emergent abnormal laboratory values, vital signs, neurological exam and ECG values will also be summarized using descriptive statistics.
Safety Review Committee A Safety Review Committee (SRC) consisting of the Investigator, Medical Monitor, and PK Scientist will review the available PK safety data to decide whether to escalate to the next higher planned dose, to repeat a dose level or to stop the dose escalation. To maintain the treatment assignment blinded, safety data will exclude treatment assignment and PK data will have blinded participant identification numbers. All SRC decisions, along with their rationale, will be documented in writing, and retained in the study files.
The data review and analysis will be based on the available Investigator-reported data in the clinical database at that time. Data to be reviewed will include safety, tolerability, and available PK data through day 8.
The Coordinating Investigator and the Sponsor, when appropriate, will invite other specialist individuals to participate in the review, eg, PK scientists, statisticians, and clinical specialists. MyMD Pharmaceuticals, Inc. will also have a board-certified cardiologist and neurologist available for consultation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: MYMD1 600mg | Experimental | Drug: MYMD-1 600MGSubjects randomly assigned to the MYMD1 600mg cohort |
| Cohort 1: Placebo 600mg | Placebo comparator | Drug: placebo 600mgSubjects assigned to the 600mg placebo group |
| Cohort 2: MYMD1 750mg | Experimental | Drug: MYMD-1 750mgSubjects randomly assigned to the MYMD1 750 cohort |
| Cohort 2: Placebo 750mg | Placebo comparator | Drug: placebo 750mgSubjects assigned to the 750mg placebo group |
| Cohort 3: MYMD1 900mg | Experimental | Drug: MYMD-1 900mgSubjects randomly assigned to the MYMD1 900mg cohort |
| Cohort 3: Placebo 900mg | Placebo comparator | Drug: placebo 900mgSubjects assigned to the 900mg placebo group |
| Cohort 4: MYMD1 1050mg | Active comparator | Drug: MYMD-1 1050mgSubjects randomly assigned to the MYMD1 1050mg cohort |
| Cohort 4: Placebo group 1050mg | Placebo comparator | Drug: placebo 1050mgSubjects assigned to the 1050mg placebo group |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Aged 65 years or older, at the time of signing the ICF
- Type of Participant and Disease Characteristics
- Elevated biomarkers of inflammation (serum IL-6 level ≥2.5 pg/mL and/or sTNFR1 level ≥1500 pg/mL)
- Low gait speed ≤ 0.8 m/s
- Short Physical Performance Battery (SPPB) score ≤8
Key exclusion criteria (26 listed)
- Taking anti-inflammatory drugs on a daily basis. Note: If the participant has been stable on their antidepressant regimen for at least 3 months and agrees not to increase the medicine for the 28 days of treatment in the trial, they may be allowed into the study
- Currently tobacco users or those who used tobacco within 30 days of study entry
- Dementia, encephalopathy or any medical condition impacting cognition
- Medical conditions that would impact mobility testing or handgrip strength including
- Rheumatoid arthritis, any autoimmune condition, Parkinson's disease, muscular dystrophy, cerebral vascular accident, lower or upper extremity neuropathy, major skeletal joint deformity, upper extremity joint dysfunction, partial or complete upper extremity amputation or missing anatomy impacting grip, history of pain with walking, gout, chronic obstructive pulmonary disease, congestive heart failure, exercise induced angina, lower extremity amputation (partial or complete) or missing anatomy impacting walking, recent surgery or hospitalization (past 3 months); lower or upper extremity fracture in the past 6 months, lower or upper extremity tendinitis, diagnosis of cancer other than basal cell carcinoma, dialysis dependent renal disease, Meniere's disease, spinal cord fracture or compression, paraplegia or quadriplegia or any other medical condition that in the opinion of the Investigator would impair measurement of a 6-minute walk or handgrip strength
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 |
|---|---|---|
| MYMD-1 600MGAlso: MYMD1 600mgCohort 1: 600mg drug | Drug | Cohort 1: MYMD1 600mg |
| MYMD-1 750mgAlso: MYMD1 750mgCohort 2: 750mg drug | Drug | Cohort 2: MYMD1 750mg |
| MYMD-1 900mgAlso: MYMD1 900mgCohort 3: 900mg drug | Drug | Cohort 3: MYMD1 900mg |
| MYMD-1 1050mgAlso: MYMD1 1050mgCohort 4: 1050mg drug | Drug | Cohort 4: MYMD1 1050mg |
| placebo 600mgAlso: placebo-600mgCohort 1: 600mg placebo | Drug | Cohort 1: Placebo 600mg |
| placebo 750mgAlso: placebo-750mgCohort 2: 750mg placebo | Drug | Cohort 2: Placebo 750mg |
| placebo 900mgAlso: placebo-900mgCohort 3: 900mg placebo | Drug | Cohort 3: Placebo 900mg |
| placebo 1050mgAlso: placebo-1050mgCohort 4: 1050mg placebo | Drug | Cohort 4: Placebo group 1050mg |
Primary outcome
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Time frame: Screening
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Time frame: Day 1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Time frame: Day 7
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Time frame: Day 14
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Time frame: Day 21
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Time frame: Day 28
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
To evaluate the PK of oral doses of MYMD1 capsules
Time frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Time frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Pharmacokinetics: Cmax - Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Time frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Pharmacokintetics: tmax - Time to Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Time frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Pharmacokinetics: t1/2 - Time to metabolize 1/2 of dose (eg, half-life) of drug substance, measured in blood plasma, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Time frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Pharmacokinetics: CL/F - Oral Clearance of the drug substance (CL/F), compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Time frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Pharmacokinetics: Volume of Distribution (V2/F ) - Volume of Distribution of the drug substance (V2/F), compared across treatment and placebo groups.
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 1 (predose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 1 (0-4 hrs post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 1 (4-8 hrs post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 1(8-24hrs post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 7 (predose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 7 (0-4 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 7 (4-8 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 7 (8-24hrs post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 14 (predose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 14 (0-4 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 14 (4-8 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 14 (8-24 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 21 (predose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK of oral doses of MYMD1 capsules
Time frame: Day 21 (0-4 hrs post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 21 (4-8 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 21 (8-24 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 28 (pre dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 28 (0-4hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 28 (4-8 hours post dose)
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Time frame: Day 28 (8-24 hours post dose)
urine sample collection for presence of parent drug - MYMD1
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 28 days
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 30 Oct 2023.
- 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.
Leonard Dunn, MD principal investigator
Clinical Research of West Florida
Lon Lynn, DO principal investigator
Clinical Research of West Florida
Jeremy Walston, MD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MYMD-1 600MG, MYMD-1 750mg and MYMD-1 900mg in people with Sarcopenia and Frailty, run by TNF Pharmaceuticals, Inc. at 3 sites in United States.
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 15 inclusion and 26 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 (time frame: Screening). The study lists 32 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 30 Oct 2023.