NCT05283486

Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: TNF Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcopenia
• Frailty
• Aging

Interventions

Type	Name	Description
DRUG	MYMD-1 600MG	Cohort 1: 600mg drug
DRUG	MYMD-1 750mg	Cohort 2: 750mg drug
DRUG	MYMD-1 900mg	Cohort 3: 900mg drug
DRUG	MYMD-1 1050mg	Cohort 4: 1050mg drug
DRUG	placebo 600mg	Cohort 1: 600mg placebo
DRUG	placebo 750mg	Cohort 2: 750mg placebo
DRUG	placebo 900mg	Cohort 3: 900mg placebo
DRUG	placebo 1050mg	Cohort 4: 1050mg placebo

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-06-07
• Completion: 2023-06-07
• First posted: 2022-03-17
• Last updated: 2023-10-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study