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

NCT05283486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • TNF Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Leonard Dunn, MD · Clinical Research of West Florida

  • Lon Lynn, DO · Clinical Research of West Florida

  • Jeremy Walston, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-06-07
Completion
2023-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283486 on ClinicalTrials.gov