Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty
Condition: Sarcopenia; Frailty; Aging
MeSH terms: Sarcopenia; Inflammation; Frailty
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): MYMD-1 600MG; MYMD-1 750mg; MYMD-1 900mg; MYMD-1 1050mg; placebo 600mg; placebo 750mg; placebo 900mg; placebo 1050mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cohort 1: 600mg drug; Cohort 2: 750mg drug; Cohort 3: 900mg drug; Cohort 4: 1050mg drug; Cohort 1: 600mg placebo; Cohort 2: 750mg placebo; Cohort 3: 900mg placebo; Cohort 4: 1050mg placebo
Other intervention name(s): MYMD1 600mg; MYMD1 750mg; MYMD1 900mg; MYMD1 1050mg; placebo-600mg; placebo-750mg; placebo-900mg; placebo-1050mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: frailty; aging; sarcopenia