CompletedPhase 1

Single Ascending-dose Study to Evaluate Safety, Tolerability, and PK of MYMD1 in Healthy Male Adult Subjects

United States40 participantsStarted 2019-06-11

Plain-language summary

Double-blind, placebo-controlled, First-in-Human, single ascending-dose study. Approximately 40 healthy adult male subjects will be given a single capsule of MYMD1 to determine its safety, how well it is tolerated, how the body acts on the experimental drug, and how the experimental drug acts on the body. This will be based on blood and urine sample analysis and other physical measurements.

Who can participate

Age range18 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written Informed Consent. * Stable medical history and general health. * Body weight between 60 - 100 kg and Body Mass Index (BMI) of 18-31 kg/m2. * Estimated GFR (eGFR) - mL/min/1.73m2 or estimated creatinine clearance (CLcr) (mL) ≥90. * Normal hepatic function. * Adequate peripheral venous access. * Test negative for HIV, hepatitis C virus antibodies, and hepatitis B surface antigen (HBsAg). * Test negative for drugs of abuse. * Willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and study center staff. * Willing to use effective contraception from Day -1 until 90 days after receiving study medication. Exclusion Criteria: * Allergy to any product ingredients. * Unable to swallow capsules. * Elective medical procedure during study. * Abusing drugs or alcohol and/or history of drug or alcohol dependence within 6 months of study entry. * History of seizure disorder requiring medical treatment after 18 years of age. * Current smoker or smokeless tobacco user. * Participation in drug or medical device clinical study within 30 days of study. entry or 5 times half-life of study drug, whichever is longer. * Medically significant standard clinical laboratory assessments. * Significant medical condition which might interfere with the study or put subject at significant risk. * QTcF \>450 ms or clinically significant ECG abnormalities. * Elevation of blood pressure (BP) - Supine BP \>145mmHg; D…

What they're measuring

Adverse Events

Timeframe: 5 days

Changes in Physical examination: Neurologic Systems

Timeframe: 5 days

Variation of MyMD1 concentration in blood plasma as a function of time

Timeframe: 5 days

Change from Baseline QTcF and QTcB

Timeframe: 5 days

Number of Patients with Changes in clinical laboratory values - Serum Chemistry: BUN, Creatinine, Glucose, Magnesium, Cholesterol, Calcium, Uric Acid, C-Reactive Protein, Total Bilirubin, Direct Bilirubin, Phosphate, and Triglycerides.

Timeframe: 5 days

Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: BUN, Creatinine, Glucose, Magnesium, Cholesterol, Calcium, Uric Acid, C-Reactive Protein, Total Bilirubin, Direct Bilirubin, Phosphate, and Triglycerides.

Timeframe: 5 days

Number of Patients with Changes in clinical laboratory values - Serum Chemistry: albumin, globulin, Total protein.

Timeframe: 5 days

Trial details

NCT IDNCT04349761

SponsorTNF Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-30

View on ClinicalTrials.gov More Undefined trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Adverse Events

Timeframe: 5 days

Changes in Physical examination: Neurologic Systems

Timeframe: 5 days

Variation of MyMD1 concentration in blood plasma as a function of time

Timeframe: 5 days

Change from Baseline QTcF and QTcB

Timeframe: 5 days

Number of Patients with Changes in clinical laboratory values - Serum Chemistry: albumin, globulin, Total protein.

Timeframe: 5 days