Hashimoto DiseasePhase 1NCT05077865

Single Ascending and Multiple Dose Study to Evaluate Safety, Tolerability, and PK of MYMD1 in Healthy Male and Female Adult Subjects

A Phase 1 study testing MYMD-1 in people with Hashimoto Disease, run by TNF Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Double-blind, placebo-controlled, single ascending and multiple dose study. Approximately 32 healthy adult male and female subjects will be given a single capsule of MYMD1 to determine its safety, tolerability, and pharmacokinetic properties. The study data will guide the establishment of an optimum therapeutic dose. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hashimoto Disease
What is being tested?: MYMD-1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 26 Apr 2021to 1 Aug 2021
Phase: Phase 1
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provide written ICF.
Is a male or female aged 18 to 65 years.
Have a stable medical history and general health as judged by the Investigator on the basis of physical examination, medical history, ECG, and the results of clinical laboratory (chemistry,hematology, coagulation, and urinalysis) testing performed at Screening.
Body mass index of 18 to 31 kg/m2, inclusive.
Have estimated glomerular filtration rate (mL/min/1.73m2) or estimated creatinine clearance ≥90 mL.
Have normal hepatic function (alanine aminotransferase: 10 to 35 U/L, aspartate aminotransferase: 9 to 46 U/L, total protein: 6.1 to 8.1 g/dL, alkaline phosphatase: 40 to 115 U/L, direct bilirubin: <0.2 mg/dL, and total bilirubin: 0.2 to 1.2 mg/dL).

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Have adequate peripheral venous access.
Test negative for human immunodeficiency virus, hepatitis C virus antibodies, and hepatitis B surface antigen.
Test negative for drugs of abuse, including oxycodone, tricyclic anti-depressants, methadone, opiates, marijuana, phencyclidines, barbiturates, methamphetamine, ecstasy, amphetamine, cocaine, and benzodiazepine.
Be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and study center staff.
Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception -

Who cannot join

Have an allergy to any of the study treatment ingredients.
Are unable to swallow capsules.
Have an elective medical procedure scheduled during the study. Bariatric surgery is also excluded.
Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study.
Have any history of seizure disorder that has required medical treatment after 18 years of age.
Current smoker or smokeless tobacco user, ie, no use of tobacco within 30 days of study entry.

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Have participated in any drug or medical device-related clinical study within 30 days of study entry.
Have values on standard clinical laboratory assessments that are deemed medically significant (show evidence of untreated significant medical illness or pose a risk of significant intercurrent illness during the study in the opinion of the Investigator).
Have any significant medical condition that could in the Investigator's opinion interfere with the study or put the subject at a significant risk. These may include, but not limited to the following: active malignant disease, current use of immune-suppressing drugs, currently taking opioid pain medication, and active seizure disorder.
On ECG, QTcF >450 ms or the presence of clinically significant abnormalities as determined by the Investigator (Screening or Day -1).
Elevation of BP, ie, supine systolic BP >145 mmHg and/or diastolic BP >92 mmHg, or heart rate >100 beats per minute at rest (Screening or Day -1). Readings that fall outside these ranges will be allowed to enter the study if they are health candidates at the Investigator's discretion.
Have gastrointestinal malabsorption.
Have abnormal renal function (defined as estimated glomerular filtration rate <90 mL/min/1.73m2 or estimated creatinine clearance <90 mL) and/or abnormal hepatic function at baseline.
Treatment with any prescription or nonprescription drugs, including vitamins, minerals, or herbal and dietary supplements, within 14 days or 5 half-lives of Day 1, whichever is longer, except Tylenol.
Use within 30 days prior to Day 1 of any drugs or substances, including grapefruit juice, that are known to strongly inhibit or induce cytochrome P450 (CYP) enzymes. If there is any question as to whether or a not a substance is permitted, please review the product labeling (if applicable) and consult the Sponsor.
Donation of blood or any blood product within 56 days of Day 1.
Willing to use effective contraception as in from Day -1 until 90 days after receiving study treatment.
Once it is confirmed that the subject meets eligibility for check-in, the subject will return approximately 5 to 7 days prior to their scheduled Day -1 to complete a COVID-19 test. All subjects will be required to have a negative test prior to check-in. A positive test will result in exclusion from the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research of West Florida, Inc
Clearwater, Florida, 33765

Other trials in United States

About this study

Official title: A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male and Female Adult Subjects

Read the detailed description

A single-center, double-blind, placebo-controlled, single ascending and multiple-dose study to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of MYMD1 capsule in healthy male and female adult subjects. Each subject will participate in the study for approximately 7-8 weeks, including a Screening period of up to 30 days, a confinement period of 2 or 5 days, and a follow-up period of approximately 5 days. In each of Cohorts 1-3, 8 subjects will be administered a single dose of either MYMD1 (N=6 in each cohort) or Placebo (N=2 in each cohort), under fasted conditions. Subjects in Cohort 4 will be administered either MYMD1 (N=6) or Placebo (N=2) on Days 1, 2, 3, 4, and 5. Each subject will participate in only 1 of the 4 cohorts during the study. Anticipated dosing levels will be 150mg (Cohort 1); 300mg (Cohort 2); 250mg (Cohort 3); and 600mg (Cohort 4).

Conditions: Hashimoto Disease
Being tested: MYMD-1, Placebo
Medical subject headings: Hashimoto Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MYMD-1Drug
Also called Isomyosamine
150 mg capsule
PlaceboDrug
Matching in appearance to MyMD-1 150mg capsule

Study groups in NCT05077865
Study group	Role	What they receive
Cohort 1 - Active	Experimental	6 subjects, randomized to receive 150mg MYMD1 (Isomyosamine), administered as one 150mg capsule on Day 1. Receives: Drug: MYMD-1
Cohort 1 - Placebo	Placebo comparator	2 subjects, randomized to receive placebo, administered on Day 1, as one capsule matching the 150mg MYMD1 capsule in appearance. Receives: Drug: Placebo
Cohort 2 - Active	Experimental	6 subjects, randomized to receive 300mg MYMD1 (Isomyosamine), administered as two 150mg capsules on Day 1. Receives: Drug: MYMD-1
Cohort 2 - Placebo	Placebo comparator	2 subjects, randomized to receive placebo, administered on Day 1, as two capsules matching the 150mg MYMD1 capsules in appearance. Receives: Drug: Placebo
Cohort 3 - Active	Experimental	6 subjects, randomized to receive 450mg MYMD1 (Isomyosamine), administered as three 150mg capsules on Day 1. Receives: Drug: MYMD-1
Cohort 3 - Placebo	Placebo comparator	2 subjects, randomized to receive placebo, administered on Day 1, as three capsules matching the 150mg MYMD1 capsules in appearance. Receives: Drug: Placebo
Cohort 4 - Active	Experimental	6 subjects, randomized to receive 600mg MYMD1 (Isomyosamine), administered as four 150mg capsules each on Days 1, 2, 3, 4, and 5. Receives: Drug: MYMD-1
Cohort 4 - Placebo	Placebo comparator	2 subjects, randomized to receive placebo, administered on Days 1, 2, 3, 4, and 5 as four capsules each, matching the 150mg MYMD1 capsules in appearance. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
Any untoward occurrence in a subject which does not necessarily have a causal relationship with this treatment. Assessed as number and percent of subjects with adverse events, compared across treatment and placebo groups.
Measured: Cohorts 1,2,3: Continuous through 13 days (includes 10 days post-discharge); Cohort 4: Continuous through 16 days (includes 10 days post-discharge)
Number of subjects with changes in clinical laboratory values - Serum Chemistry: BUN, Creatinine, Glucose, Magnesium, Cholesterol, Calcium, Uric Acid, C-Reactive Protein, T Bili, D Bili, Phosphate, and Triglycerides.
Number of subjects with clinically significant changes from Baseline in Blood Urea Nitrogen (BUN); Creatinine; Glucose (fasting); Magnesium; Cholesterol; Calcium; Uric Acid; C-Reactive Protein; Total Bilirubin; Direct Bilirubin; Phosphate; and Triglycerides, compared across treatment and Placebo groups. All tests measured in mg/dL.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: albumin, globulin, Total protein.
Number of patients with clinically significant changes from Baseline in albumin, globulin, and total protein, compared across treatment and Placebo groups.
All tests measured in g/dL.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: Electrolytes
Number of subjects with clinically significant changes from Baseline in Potassium, Sodium, Chloride, and Carbon Dioxide (bicarbonate), compared across treatment and Placebo groups. All tests measured in mmol/L.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: Creatine Kinase muscle/brain (MB) fraction
Number of subjects with clinically significant changes from Baseline in Creatine Kinase muscle/brain (MB) fraction, compared across treatment and Placebo groups.
All tests measured in ng/mL.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: Gamma Glutamyl Transferase (GTT), Lactate dehydrogenase, Aspartate Aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Creatine kinase, and Amylase
Number of subjects with clinically significant changes from Baseline in Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT), Alkaline phosphatase, Creatine kinase, and Amylase, compared across treatment and Placebo groups.
All tests measured in U/L.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of Subjects with changes in clinical laboratory values - Hematology: Red Blood Cell (RBC) count
Number of subjects with clinically significant changes from Baseline in Red Blood Cell (RBC) count, compared across treatment and Placebo groups.
All tests measured in Millions/microL.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Hematology: Platelet count, White Blood Cell count
Number of subjects with clinically significant changes from Baseline in Platelet count and White Blood Cell count, compared across treatment and Placebo groups.
All tests measured in Thousands/microL.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Hematology: Hematocrit, Reticulocytes
Number of subjects with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups.
All tests measured in %.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Hematology: Mean corpuscular volume, Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils
Number of subjects with clinically significant changes from Baseline in Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils, compared across treatment and Placebo groups.
All tests measured in cells/microL.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - Hematology: Mean corpuscular hemoglobin
Number of subjects with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups.
All tests measured in pg.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - coagulation: Fibrinogen
Number of subjects with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with changes in clinical laboratory values - coagulation: Prothrombin time, Activated partial thromboplastin time, Thrombin time
Number of subjects with clinically significant changes from Baseline time, Activated partial thromboplastin time, Thrombin time compared across treatment and Placebo groups.
All tests measured in seconds (sec).
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Urinalysis: Microscopic
Number and percent of subjects with clinically significant changes from Baseline in Red Blood Cell (RBC), Epithelial Cells, Bacteria, Casts, and White Blood Cell (WBC) counts, compared across treatment and Placebo groups. All units measured as /lpf.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Urinalysis: Urobilinogen
Number and percent of subjects with clinically significant changes from Baseline in Urobilinogen (eu/dL), compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Changes in Electrocardiogram (ECG): Heart Rate
Number of subjects with clinically significant changes from Baseline in Electrocardiogram (12-lead ECG) measures of Heart Rate (beats per minute - bpm). Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms"
Measured: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.
Changes in Electrocardiogram (ECG): PR, RR, QRS, QT, QTcF, and QTcB
12-lead. Number of subjects with changes from Baseline Elecrocardiogram (12-lead ECG) measures of PR Interval (ms); RR Interval (ms); QRS Interval (ms); QT Interval (ms); QTcF Interval (ms); and QTcB Interval (ms)
Measured: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.
Change from Baseline QTcF and QTcB
Clinically meaningful changes in cardiac rhythm pertaining to QT interval, derived from centrally-overread 12-lead ECGs, measured in triplicate, based on Holter monitoring. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.
Changes in Physical examination: Head, eye, ear, nose, and throat
Otolaryngologic head, eye, ear, nose, and throat exam, based on Investigator observation, based on experience, education, and training. Visual assessment of clinical appearance. Ear examined using a flashlight. Throat examined using a tongue depressor. Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Changes in Physical examination: Cardiovascular
Assessed by Investigator, based on education, training, and experience, using stethoscope, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Changes in Physical examination: General Appearance
Physical signs and symptoms assessed by Investigator observation, based on experience, education, and training. May include observation of obesity or dermatologic conditions. Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Changes in Physical examination: Respiratory
Respiratory function, measured in breaths per minute (bpm) Assessed by Investigator, based on education, experience, and training, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Changes in Physical examination: Gastrointestinal
Gastrointestinal signs and symptoms. May include evaluation of normal bowel movements or abdominal pain. Assessed by Investigator, based on education, experience, and training, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Changes in Physical examination: Body Weight
Body Weight measured in kg, using scale. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Days -1, 8; Cohort 4: Days -1, 5, 6
Pharmacokinetics: AUC
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: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Pharmacokinetics: Cmax
Cmax - Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Pharmacokinetics: tmax
tmax - Time to Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 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.
Measured: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Pharmacokinetics: CL/F
Oral Clearance of the drug substance (CL/F), compared across treatment and placebo groups.
Measured: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
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: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Pharmacokinetics: Urine presence of MYMD1
urine sample collection for presence of Keystone parent drug - MYMD1 (Isomyosamine)
Measured: Cohorts 1, 2, 3, 4: Hours 0-4, 4-8, 8-12, 12-16, 16-24, 24-32, 32-40, 40-48; Additional timepoints for Cohort 4 only: Day 3 - Hours 0-8, 8-16, 16-24, Day 4 - Hours 0-8, 8-16, 16-24, Day 5 - Hours 0-8, 8-16, 16-24.
Vital signs: Oral Temperature (degrees Centigrade)
Oral temperature, using oral thermometer. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.
Vital Signs: Pulse Rate
Pulse rate measured in beats per minute (bpm). Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.
Vital signs: Blood Pressure
Sitting diastolic and systolic blood pressure, measured by Karotkoff Cuff in mmHg. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.
Vital signs: Respiratory Rate
Respiratory rate, measured in breaths per minute (bpm). Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.

Secondary outcomes (9)

Pharmacokinetics: AUC
Area Under the Curve (AUC) (0-last), (0-inf), (0-24): variation of MYMD1 concentration, as a function of time
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: Cmax
Maximum concentration (Cmax) of MYMD1 in blood plasma
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: Tmax
Time to maximum concentration (Tmax) of MYMD1 in blood plasma
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: T1/2
Time to metabolism of half of MYMD1 (eg, half-life) (T1/2) in blood plasma. A minimum of 3 points will be used for estimation
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: CL/F
Oral clearance (CL/F) of MYMD1
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: Vz/F
Apparent volume of Distribution of MYMD1
Measured: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Biomarker Assessment: Tissue Necrosis Factor (TNF) alpha (TNF-α)
Biomarker TNF-α results will be summarized descriptively by dose, using appropriate statistics. Both change from Baseline, expressed as difference (difference between postdose and predose result) as well as the fractional change (postdose/Baseline expressed as percent) will be presented, if appropriate.
Measured: Cohorts 1, 2, 3: Hours 2 and 48; Cohort 4: Hours 2, 48, 96, and 120.
Biomarker Assessment: Pyridyloxobutyl (POB) adducts in hemophilia
Biomarker Pyridyloxobutyl (POB) adducts in hemophilia results will be summarized descriptively by dose, using appropriate statistics. Both change from Baseline, expressed as difference (difference between postdose and predose result) as well as the fractional change (postdose/Baseline expressed as percent) will be presented, if appropriate.
Measured: Cohorts 1, 2, 3: Hours 2 and 48; Cohort 4: Hours 2, 48, 96, and 120.
Cardiovascular: QTcF
To quantify the relationship between plasma concentrations of MyMD1 and change from Baseline QTcF. Change from baseline QTcF, derived from locally overread ECGs measured in triplicates.
Measured: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 20211 Aug 2021

First posted14 Oct 2021
Study start26 Apr 2021
Primary completion1 Aug 2021
Study completion1 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hashimoto DiseaseStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blind, randomized, placebo-controlled study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05077865
Sponsor's protocol ID: MyMD-PK-002
Status last verified: Mar 2023
First submitted: 1 Oct 2021
Last updated: 27 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male and Female Adult Subjects
ClinicalTrials.gov ID: NCT05077865
Acronym / sponsor ID: MyMD-PK-002
Conditions: Hashimoto Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: TNF Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 26 Apr 2021 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 1 Aug 2021 (actual)
First posted: 14 Oct 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8
Model description: Double-blind, randomized, placebo-controlled study

Arm	Type	Receives
Cohort 1 - Active	Experimental	Drug: MYMD-16 subjects, randomized to receive 150mg MYMD1 (Isomyosamine), administered as one 150mg capsule on Day 1.
Cohort 1 - Placebo	Placebo comparator	Drug: Placebo2 subjects, randomized to receive placebo, administered on Day 1, as one capsule matching the 150mg MYMD1 capsule in appearance.
Cohort 2 - Active	Experimental	Drug: MYMD-16 subjects, randomized to receive 300mg MYMD1 (Isomyosamine), administered as two 150mg capsules on Day 1.
Cohort 2 - Placebo	Placebo comparator	Drug: Placebo2 subjects, randomized to receive placebo, administered on Day 1, as two capsules matching the 150mg MYMD1 capsules in appearance.
Cohort 3 - Active	Experimental	Drug: MYMD-16 subjects, randomized to receive 450mg MYMD1 (Isomyosamine), administered as three 150mg capsules on Day 1.
Cohort 3 - Placebo	Placebo comparator	Drug: Placebo2 subjects, randomized to receive placebo, administered on Day 1, as three capsules matching the 150mg MYMD1 capsules in appearance.
Cohort 4 - Active	Experimental	Drug: MYMD-16 subjects, randomized to receive 600mg MYMD1 (Isomyosamine), administered as four 150mg capsules each on Days 1, 2, 3, 4, and 5.
Cohort 4 - Placebo	Placebo comparator	Drug: Placebo2 subjects, randomized to receive placebo, administered on Days 1, 2, 3, 4, and 5 as four capsules each, matching the 150mg MYMD1 capsules in appearance.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Provide written ICF.
Is a male or female aged 18 to 65 years.
Have a stable medical history and general health as judged by the Investigator on the basis of physical examination, medical history, ECG, and the results of clinical laboratory (chemistry,hematology, coagulation, and urinalysis) testing performed at Screening.
Body mass index of 18 to 31 kg/m2, inclusive.
Have estimated glomerular filtration rate (mL/min/1.73m2) or estimated creatinine clearance ≥90 mL.

Key exclusion criteria (18 listed)

Have an allergy to any of the study treatment ingredients.
Are unable to swallow capsules.
Have an elective medical procedure scheduled during the study. Bariatric surgery is also excluded.
Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study.
Have any history of seizure disorder that has required medical treatment after 18 years of age.

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-1Also: Isomyosamine150 mg capsule	Drug	Cohort 1 - Active, Cohort 2 - Active, Cohort 3 - Active, Cohort 4 - Active
PlaceboMatching in appearance to MyMD-1 150mg capsule	Drug	Cohort 1 - Placebo, Cohort 2 - Placebo, Cohort 3 - Placebo, Cohort 4 - Placebo

Primary outcome

Adverse Events
Time frame: Cohorts 1,2,3: Continuous through 13 days (includes 10 days post-discharge); Cohort 4: Continuous through 16 days (includes 10 days post-discharge)
Any untoward occurrence in a subject which does not necessarily have a causal relationship with this treatment. Assessed as number and percent of subjects with adverse events, compared across treatment and placebo groups.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: BUN, Creatinine, Glucose, Magnesium, Cholesterol, Calcium, Uric Acid, C-Reactive Protein, T Bili, D Bili, Phosphate, and Triglycerides.
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Blood Urea Nitrogen (BUN); Creatinine; Glucose (fasting); Magnesium; Cholesterol; Calcium; Uric Acid; C-Reactive Protein; Total Bilirubin; Direct Bilirubin; Phosphate; and Triglycerides, compared across treatment and Placebo groups. All tests measured in mg/dL.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: albumin, globulin, Total protein.
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of patients with clinically significant changes from Baseline in albumin, globulin, and total protein, compared across treatment and Placebo groups. All tests measured in g/dL.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: Electrolytes
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Potassium, Sodium, Chloride, and Carbon Dioxide (bicarbonate), compared across treatment and Placebo groups. All tests measured in mmol/L.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: Creatine Kinase muscle/brain (MB) fraction
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Creatine Kinase muscle/brain (MB) fraction, compared across treatment and Placebo groups. All tests measured in ng/mL.
Number of subjects with changes in clinical laboratory values - Serum Chemistry: Gamma Glutamyl Transferase (GTT), Lactate dehydrogenase, Aspartate Aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Creatine kinase, and Amylase
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT), Alkaline phosphatase, Creatine kinase, and Amylase, compared across treatment and Placebo groups. All tests measured in U/L.
Number of Subjects with changes in clinical laboratory values - Hematology: Red Blood Cell (RBC) count
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Red Blood Cell (RBC) count, compared across treatment and Placebo groups. All tests measured in Millions/microL.
Number of subjects with changes in clinical laboratory values - Hematology: Platelet count, White Blood Cell count
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Platelet count and White Blood Cell count, compared across treatment and Placebo groups. All tests measured in Thousands/microL.
Number of subjects with changes in clinical laboratory values - Hematology: Hematocrit, Reticulocytes
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups. All tests measured in %.
Number of subjects with changes in clinical laboratory values - Hematology: Mean corpuscular volume, Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils, compared across treatment and Placebo groups. All tests measured in cells/microL.
Number of subjects with changes in clinical laboratory values - Hematology: Mean corpuscular hemoglobin
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups. All tests measured in pg.
Number of subjects with changes in clinical laboratory values - coagulation: Fibrinogen
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.
Number of subjects with changes in clinical laboratory values - coagulation: Prothrombin time, Activated partial thromboplastin time, Thrombin time
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number of subjects with clinically significant changes from Baseline time, Activated partial thromboplastin time, Thrombin time compared across treatment and Placebo groups. All tests measured in seconds (sec).
Urinalysis: Microscopic
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number and percent of subjects with clinically significant changes from Baseline in Red Blood Cell (RBC), Epithelial Cells, Bacteria, Casts, and White Blood Cell (WBC) counts, compared across treatment and Placebo groups. All units measured as /lpf.
Urinalysis: Urobilinogen
Time frame: Cohorts 1, 2, 3: Days 2 and 8; Cohort 4: Days 2, 4, 5, 6, & 8.
Number and percent of subjects with clinically significant changes from Baseline in Urobilinogen (eu/dL), compared across treatment and Placebo groups.
Changes in Electrocardiogram (ECG): Heart Rate
Time frame: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.
Number of subjects with clinically significant changes from Baseline in Electrocardiogram (12-lead ECG) measures of Heart Rate (beats per minute - bpm). Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms"
Changes in Electrocardiogram (ECG): PR, RR, QRS, QT, QTcF, and QTcB
Time frame: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.
12-lead. Number of subjects with changes from Baseline Elecrocardiogram (12-lead ECG) measures of PR Interval (ms); RR Interval (ms); QRS Interval (ms); QT Interval (ms); QTcF Interval (ms); and QTcB Interval (ms)
Change from Baseline QTcF and QTcB
Time frame: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.
Clinically meaningful changes in cardiac rhythm pertaining to QT interval, derived from centrally-overread 12-lead ECGs, measured in triplicate, based on Holter monitoring. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and placebo groups.
Changes in Physical examination: Head, eye, ear, nose, and throat
Time frame: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Otolaryngologic head, eye, ear, nose, and throat exam, based on Investigator observation, based on experience, education, and training. Visual assessment of clinical appearance. Ear examined using a flashlight. Throat examined using a tongue depressor. Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Cardiovascular
Time frame: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Assessed by Investigator, based on education, training, and experience, using stethoscope, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: General Appearance
Time frame: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Physical signs and symptoms assessed by Investigator observation, based on experience, education, and training. May include observation of obesity or dermatologic conditions. Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Respiratory
Time frame: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Respiratory function, measured in breaths per minute (bpm) Assessed by Investigator, based on education, experience, and training, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Gastrointestinal
Time frame: Cohorts 1, 2, 3: Days -1, 2, 3, 8; Cohort 4: Days -1, 3, 5, 6, 11
Gastrointestinal signs and symptoms. May include evaluation of normal bowel movements or abdominal pain. Assessed by Investigator, based on education, experience, and training, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Body Weight
Time frame: Cohorts 1, 2, 3: Days -1, 8; Cohort 4: Days -1, 5, 6
Body Weight measured in kg, using scale. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Pharmacokinetics: AUC
Time frame: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 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.
Pharmacokinetics: Cmax
Time frame: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Cmax - Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Pharmacokinetics: tmax
Time frame: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
tmax - Time to Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Pharmacokinetics: t1/2
Time frame: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Time to metabolize 1/2 of dose (eg, half-life) of drug substance, measured in blood plasma, compared across treatment and placebo groups.
Pharmacokinetics: CL/F
Time frame: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Oral Clearance of the drug substance (CL/F), compared across treatment and placebo groups.
Pharmacokinetics: Volume of Distribution (V2/F )
Time frame: Cohorts 1, 2, 3: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 hrs; Cohort 4: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hrs.
Volume of Distribution of the drug substance (V2/F), compared across treatment and placebo groups.
Pharmacokinetics: Urine presence of MYMD1
Time frame: Cohorts 1, 2, 3, 4: Hours 0-4, 4-8, 8-12, 12-16, 16-24, 24-32, 32-40, 40-48; Additional timepoints for Cohort 4 only: Day 3 - Hours 0-8, 8-16, 16-24, Day 4 - Hours 0-8, 8-16, 16-24, Day 5 - Hours 0-8, 8-16, 16-24.
urine sample collection for presence of Keystone parent drug - MYMD1 (Isomyosamine)
Vital signs: Oral Temperature (degrees Centigrade)
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.
Oral temperature, using oral thermometer. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Vital Signs: Pulse Rate
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.
Pulse rate measured in beats per minute (bpm). Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Vital signs: Blood Pressure
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.
Sitting diastolic and systolic blood pressure, measured by Karotkoff Cuff in mmHg. Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Vital signs: Respiratory Rate
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 1, 2, 4, 6, 12, 24, 48, 168; Cohort 4: Hours 0.5, 1, 2, 4, 6, 12, 24, 48, 72, 120, 240.
Respiratory rate, measured in breaths per minute (bpm). Assessed as number and percent of subjects with clinically significant changes from Baseline, compared across treatment and Placebo groups.

9 secondary outcomes

Pharmacokinetics: AUC
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: Cmax
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: Tmax
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: T1/2
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: CL/F
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Pharmacokinetics: Vz/F
Time frame: Cohorts 1, 2, 3: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48; Cohort 4: Hours 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96
Biomarker Assessment: Tissue Necrosis Factor (TNF) alpha (TNF-α)
Time frame: Cohorts 1, 2, 3: Hours 2 and 48; Cohort 4: Hours 2, 48, 96, and 120.
Biomarker Assessment: Pyridyloxobutyl (POB) adducts in hemophilia
Time frame: Cohorts 1, 2, 3: Hours 2 and 48; Cohort 4: Hours 2, 48, 96, and 120.
Cardiovascular: QTcF
Time frame: Cohorts 1, 2, 3: 0.5, 1, 4, 24, 48, 168 hrs; Cohort 4: 0.5, 1, 4, 24, 48, 72, 96, 240 hrs.

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 27 Mar 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, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MYMD-1 in people with Hashimoto Disease, run by TNF Pharmaceuticals, Inc. at 1 site 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 11 inclusion and 18 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Adverse Events (time frame: Cohorts 1,2,3: Continuous through 13 days (includes 10 days post-discharge); Cohort 4: Continuous through 16 days (includes 10 days post-discharge)). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077865.

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 27 Mar 2023.