UndefinedPhase 1NCT04349761
Single Ascending-dose Study to Evaluate Safety, Tolerability, and PK of MYMD1 in Healthy Male Adult Subjects
A Phase 1 study testing MyMD1 in people with Undefined, run by TNF Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Undefined
- What is being tested?
- MyMD1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2019to 30 Dec 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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; Diastolic BP. >92mmHg;l heart rate (HR) >100 bpm.
- Gastrointestinal malabsorption.
- Abnormal thyroid function (TSH, T4 and/or T3 levels): elevated thyroid antibodies (anti- TPO and/or anti-Thyroglobulin); thyroid goiter, or known thyroid nodule(s) at Baseline; >Abnormal renal function (estimated GFR >90mL/min/1.73m2 or estimated creatinine clearance <90mL) 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.
- Donation of blood or blood product within 56 days of Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, First-in-human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male Adult Subjects
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.
Read the detailed description
A single-center, double-blind, placebo-controlled, first-in-human, single ascending-dose study to evaluate the safety, tolerability, and pharmacokinetics of single oral dose capsules of MYMD1 in healthy male adult subjects. Each subject will participate in the study for approximately 7 weeks, including a Screening period of up to 30 days, a confinement period of 4 days, and a follow-up period of approximately 2 weeks. In each cohort, 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, and each subject will participate in only 1 of the 5 cohorts during the study. Anticipated dosing levels will be 5mg (Cohort 1), 10mg (Cohort 2), 15mg (Cohort 3), 20mg (Cohort 4), and 25mg (Cohort 5). Sentinel dosing will be used to initiate each cohort, and the first 2 subjects will be randomized 1:1 to receive either MYMD1 or Placebo. The remaining subjects will be dosed 5:1 to receive either MYMD1 or Placebo, respectively.
- Conditions
- Undefined
- Being tested
- MyMD1, Placebo
- Keywords
- Pharmacokinetics, Phase I, First-in-Human, Safety, Tolerability, Hashimoto thyroiditis, Autoimmune
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMD1Drug
Isomyosamine 5mg capsules
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 5mg MyMD1 | Experimental | 8 subjects randomized to receive either 5mg MyMD1 (6 subjects) or Placebo (2 subjects) Receives: Drug: MyMD1; Drug: Placebo |
| Cohort 2 - 10mg MyMD1 | Experimental | 8 subjects randomized to receive either 10mg MyMD1 (6 subjects) or Placebo (2 subjects) Receives: Drug: MyMD1; Drug: Placebo |
| Cohort 3 - 15mg MyMD1 | Experimental | 8 subjects randomized to receive either 15mg MyMD1 (6 subjects) or Placebo (2 subjects) Receives: Drug: MyMD1; Drug: Placebo |
| Cohort 4 - 20mg MyMD1 | Experimental | 8 subjects randomized to receive either 20mg MyMD1 (6 subjects) or Placebo (2 subjects) Receives: Drug: MyMD1; Drug: Placebo |
| Cohort 5 - 25mg MyMD1 or Placebo | Experimental | 8 subjects randomized to receive either 25mg MyMD1 (6 subjects) or Placebo (2 subjects) Receives: Drug: MyMD1; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment. Assessed as number and percent of patients with adverse events, compared across treatment and Placebo groups .
Measured: 5 days
Changes in Physical examination: Neurologic Systems
Neurologic systems, including testing of patellar reflex using rubber mallet. 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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
Variation of MyMD1 concentration in blood plasma as a function of time
AUC (0-inf)
Measured: 5 days
Change from Baseline QTcF and QTcB
Derived from centrally-overread 12-lead ECGs, measured in triplicate, based on Holter monitoring. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 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.
Number of patients 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: 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.
Percentage of patients 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: 5 days
Number of Patients 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: 5 days
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: albumin, globulin, Total protein.
Percentage 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: 5 days
Number of Patients with Changes in clinical laboratory values - Serum Chemistry: Electrolytes
Number of patients 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: 5 days
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: Electrolytes
Percentage of patients 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: 5 days
Number of Patients with Changes in clinical laboratory values - Serum Chemistry: Creatine Kinase muscle/brain (MB) fraction
Number of patients 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: 5 days
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: Creatine Kinase muscle/brain (MB) fraction
Percentage of patients 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: 5 days
Number of Patients with Changes in clinical laboratory values - Serum Chemistry: Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Creatine kinase, and Amylase
Number of patients 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: 5 days
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Creatine kinase, and Amylase
Percentage of patients 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: 5 days
Number of Patients with Changes in clinical laboratory values - Hematology:Red Blood Cell count
Number of patients with clinically significant changes from Baseline in Red Blood Cell count, compared across treatment and Placebo groups. All tests measured in Millions/microL.
Measured: 5 days
Percentage of Patients with Changes in clinical laboratory values - Hematology:Red Blood Cell count
Percentage of patients with clinically significant changes from Baseline in Red Blood Cell count, compared across treatment and Placebo groups. All tests measured in Millions/microL.
Measured: 5 days
Number of Patients with Changes in clinical laboratory values - Hematology: Platelet count, White Blood Cell count
Number of patients 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: 5 days
Percentage of Patients with Changes in clinical laboratory values - Hematology: Platelet count, White Blood Cell count
Percentage of patients 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: 5 days
Number of Patients with Changes in clinical laboratory values - Hematology: Hematocrit, Reticulocytes
Number of patients with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups. All tests measured in %.
Measured: 5 days
Percentage of Patients with Changes in clinical laboratory values - Hematology: Hematocrit, Reticulocytes
Percentage of patients with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups. All tests measured in %.
Measured: 5 days
Number of Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular volume, Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils
Number of patients 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: 5 days
Percentage of Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular volume, Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils
Percentage of patients 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: 5 days
Number of Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular hemoglobin
Number of patients with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups. All tests measured in pg.
Measured: 5 days
Percentage of Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular hemoglobin
Percentage of patients with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups. All tests measured in pg.
Measured: 5 days
Number of Patients with Changes in clinical laboratory values - coagulation: Fibrinogen
Number of patients with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.
Measured: 5 days
Percentage of Patients with Changes in clinical laboratory values - coagulation: Fibrinogen
Percentage of patients with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.
Measured: 5 days
Number of Patients with Changes in clinical laboratory values - coagulation: Prothrombin time, Activated partial thromboplastin time, Thrombin time
Number of patients 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: 5 days
Percentage of Patients with Changes in clinical laboratory values - coagulation: Prothrombin time, Activated partial thromboplastin time, Thrombin time
Percentage of patients 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: 5 days
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: 5 days
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: 5 days
Changes in Electrocardiogram (ECG): Heart Rate
12-lead; Number of patients with clinically significant changes from Baseline in Electrocardiogram (ECG) measures of Heart Rate (beats per minute - bpm). Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms"
Measured: 5 days
Changes in Electrocardiogram (ECG): PR, RR, QRS, QT, QTcF, and QTcB
12-lead. Number of patients with changes from Baseline in PR Interval (ms); RR Intermal (ms); QRS Interval (ms); QT Interval (ms); QTcF Interval (ms); and QTcB Interval (ms)
Measured: Time of Assessment (24-Hour Clock)
Vital signs: Oral Temperature (degrees Centigrade)
Oral temperature, using oral thermometer. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
Changes in Physical examination: Respiratory
Respiratory, 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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
Changes in Physical examination: Body Weight
Body Weight measured in kg using scale. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
Changes in Physical examination: Height
Height (cm) measured using ruler attached to weighing scale.
Measured: 5 days
Pharmacokinetics: AUC
Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time
Measured: 5 days
Pharmacokinetics: Cmax
Cmax - Maximum Concentration of drug substance in blood plasma
Measured: 5 days
Pharmacokinetics: tmax
tmax - Time to Maximum Concentration of drug substance in blood plasma
Measured: 5 days
Pharmacokinetics: t 1/2
Time to metabolism of 1/2 of dose (eg, half-life) of drug substance in blood plasma
Measured: 5 days
Pharmacokinetics: CL/F
Oral Clearance of the drug substance (CL/F)
Measured: 5 days
Pharmacokinetics: V2/F
V2/F
Measured: 5 days
Vital Signs: Pulse Rate
pulse rate measured in beats per minute (bpm). Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
Vital signs: Blood Pressure
Sitting diastolic and systolic blood pressure, measured by Karotkoff Cuff in mmHg. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
Vital signs: Respiratory Rate
Respiratory rate, measured in breaths per minute. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Measured: 5 days
Thyroid Test: Trilodothyronine (Free T3)
Number and percent of patients with clinically significant changes from Baseline in Free T3 (pg/mL), compared across treatment and Placebo groups.
Measured: 5 days
Thyroid Test: Thyroxine (Free T4)
Number and percent of patients with clinically significant changes from Baseline in Free T4 (ng/dL), compared across treatment and Placebo groups.
Measured: 5 days
Thyroid Test: Thyroid Stimulating Hormone (TSH)
Number and percent of patients with clinically significant changes from Baseline in TSH (mIU/L), compared across treatment and Placebo groups.
Measured: 5 days
Urinalysis: Urobilinogen
Number and percent of patients with clinically significant changes from Baseline in Urobilinogen (eu/dL), compared across treatment and Placebo groups.
Measured: 5 days
Urinalysis (Microscopic)
Number and percent of patients 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: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start11 Jun 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndefinedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, single ascending dose study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNF Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Art Simon, PhD, Study director, Palm Beach CRO, LLCLeonard J Dunn, MD, Principal investigator, Clinical Research of West Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349761
- Sponsor's protocol ID
- MyMD-PK-001
- Status last verified
- Apr 2020
- First submitted
- 10 Feb 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, First-in-human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male Adult Subjects
- ClinicalTrials.gov ID
- NCT04349761
- Acronym / sponsor ID
- MyMD-PK-001
- Conditions
- Undefined
- Keywords
- Pharmacokinetics, Phase I, First-in-Human, Safety, Tolerability, Hashimoto thyroiditis, Autoimmune
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TNF Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 16 Apr 2020 (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.
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.
Detailed description
A single-center, double-blind, placebo-controlled, first-in-human, single ascending-dose study to evaluate the safety, tolerability, and pharmacokinetics of single oral dose capsules of MYMD1 in healthy male adult subjects. Each subject will participate in the study for approximately 7 weeks, including a Screening period of up to 30 days, a confinement period of 4 days, and a follow-up period of approximately 2 weeks. In each cohort, 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, and each subject will participate in only 1 of the 5 cohorts during the study. Anticipated dosing levels will be 5mg (Cohort 1), 10mg (Cohort 2), 15mg (Cohort 3), 20mg (Cohort 4), and 25mg (Cohort 5). Sentinel dosing will be used to initiate each cohort, and the first 2 subjects will be randomized 1:1 to receive either MYMD1 or Placebo. The remaining subjects will be dosed 5:1 to receive either MYMD1 or Placebo, respectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Double-blind, placebo-controlled, single ascending dose study.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 5mg MyMD1 | Experimental | Drug: MyMD1, Drug: Placebo8 subjects randomized to receive either 5mg MyMD1 (6 subjects) or Placebo (2 subjects) |
| Cohort 2 - 10mg MyMD1 | Experimental | Drug: MyMD1, Drug: Placebo8 subjects randomized to receive either 10mg MyMD1 (6 subjects) or Placebo (2 subjects) |
| Cohort 3 - 15mg MyMD1 | Experimental | Drug: MyMD1, Drug: Placebo8 subjects randomized to receive either 15mg MyMD1 (6 subjects) or Placebo (2 subjects) |
| Cohort 4 - 20mg MyMD1 | Experimental | Drug: MyMD1, Drug: Placebo8 subjects randomized to receive either 20mg MyMD1 (6 subjects) or Placebo (2 subjects) |
| Cohort 5 - 25mg MyMD1 or Placebo | Experimental | Drug: MyMD1, Drug: Placebo8 subjects randomized to receive either 25mg MyMD1 (6 subjects) or Placebo (2 subjects) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| MyMD1Isomyosamine 5mg capsules | Drug | Cohort 1 - 5mg MyMD1, Cohort 2 - 10mg MyMD1, Cohort 3 - 15mg MyMD1, Cohort 4 - 20mg MyMD1, Cohort 5 - 25mg MyMD1 or Placebo |
| PlaceboPlacebo | Drug | Cohort 1 - 5mg MyMD1, Cohort 2 - 10mg MyMD1, Cohort 3 - 15mg MyMD1, Cohort 4 - 20mg MyMD1, Cohort 5 - 25mg MyMD1 or Placebo |
Primary outcome
Adverse Events
Time frame: 5 days
Any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment. Assessed as number and percent of patients with adverse events, compared across treatment and Placebo groups .
Changes in Physical examination: Neurologic Systems
Time frame: 5 days
Neurologic systems, including testing of patellar reflex using rubber mallet. 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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Variation of MyMD1 concentration in blood plasma as a function of time
Time frame: 5 days
AUC (0-inf)
Change from Baseline QTcF and QTcB
Time frame: 5 days
Derived from centrally-overread 12-lead ECGs, measured in triplicate, based on Holter monitoring. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
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.
Time frame: 5 days
Number of patients 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.
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.
Time frame: 5 days
Percentage of patients 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 Patients with Changes in clinical laboratory values - Serum Chemistry: albumin, globulin, Total protein.
Time frame: 5 days
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.
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: albumin, globulin, Total protein.
Time frame: 5 days
Percentage 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 Patients with Changes in clinical laboratory values - Serum Chemistry: Electrolytes
Time frame: 5 days
Number of patients 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.
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: Electrolytes
Time frame: 5 days
Percentage of patients 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 Patients with Changes in clinical laboratory values - Serum Chemistry: Creatine Kinase muscle/brain (MB) fraction
Time frame: 5 days
Number of patients 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.
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: Creatine Kinase muscle/brain (MB) fraction
Time frame: 5 days
Percentage of patients 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 Patients with Changes in clinical laboratory values - Serum Chemistry: Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Creatine kinase, and Amylase
Time frame: 5 days
Number of patients 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.
Percentage of Patients with Changes in clinical laboratory values - Serum Chemistry: Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Creatine kinase, and Amylase
Time frame: 5 days
Percentage of patients 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 Patients with Changes in clinical laboratory values - Hematology:Red Blood Cell count
Time frame: 5 days
Number of patients with clinically significant changes from Baseline in Red Blood Cell count, compared across treatment and Placebo groups. All tests measured in Millions/microL.
Percentage of Patients with Changes in clinical laboratory values - Hematology:Red Blood Cell count
Time frame: 5 days
Percentage of patients with clinically significant changes from Baseline in Red Blood Cell count, compared across treatment and Placebo groups. All tests measured in Millions/microL.
Number of Patients with Changes in clinical laboratory values - Hematology: Platelet count, White Blood Cell count
Time frame: 5 days
Number of patients 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.
Percentage of Patients with Changes in clinical laboratory values - Hematology: Platelet count, White Blood Cell count
Time frame: 5 days
Percentage of patients 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 Patients with Changes in clinical laboratory values - Hematology: Hematocrit, Reticulocytes
Time frame: 5 days
Number of patients with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups. All tests measured in %.
Percentage of Patients with Changes in clinical laboratory values - Hematology: Hematocrit, Reticulocytes
Time frame: 5 days
Percentage of patients with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups. All tests measured in %.
Number of Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular volume, Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils
Time frame: 5 days
Number of patients 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.
Percentage of Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular volume, Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils
Time frame: 5 days
Percentage of patients 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 Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular hemoglobin
Time frame: 5 days
Number of patients with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups. All tests measured in pg.
Percentage of Patients with Changes in clinical laboratory values - Hematology: Mean corpuscular hemoglobin
Time frame: 5 days
Percentage of patients with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups. All tests measured in pg.
Number of Patients with Changes in clinical laboratory values - coagulation: Fibrinogen
Time frame: 5 days
Number of patients with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.
Percentage of Patients with Changes in clinical laboratory values - coagulation: Fibrinogen
Time frame: 5 days
Percentage of patients with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.
Number of Patients with Changes in clinical laboratory values - coagulation: Prothrombin time, Activated partial thromboplastin time, Thrombin time
Time frame: 5 days
Number of patients 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).
Percentage of Patients with Changes in clinical laboratory values - coagulation: Prothrombin time, Activated partial thromboplastin time, Thrombin time
Time frame: 5 days
Percentage of patients 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).
Changes in Physical examination: Cardiovascular
Time frame: 5 days
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: Head, eye, ear, nose, and throat
Time frame: 5 days
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 Electrocardiogram (ECG): Heart Rate
Time frame: 5 days
12-lead; Number of patients with clinically significant changes from Baseline in Electrocardiogram (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: Time of Assessment (24-Hour Clock)
12-lead. Number of patients with changes from Baseline in PR Interval (ms); RR Intermal (ms); QRS Interval (ms); QT Interval (ms); QTcF Interval (ms); and QTcB Interval (ms)
Vital signs: Oral Temperature (degrees Centigrade)
Time frame: 5 days
Oral temperature, using oral thermometer. 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: 5 days
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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Respiratory
Time frame: 5 days
Respiratory, 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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Gastrointestinal
Time frame: 5 days
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 patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Body Weight
Time frame: 5 days
Body Weight measured in kg using scale. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Changes in Physical examination: Height
Time frame: 5 days
Height (cm) measured using ruler attached to weighing scale.
Pharmacokinetics: AUC
Time frame: 5 days
Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time
Pharmacokinetics: Cmax
Time frame: 5 days
Cmax - Maximum Concentration of drug substance in blood plasma
Pharmacokinetics: tmax
Time frame: 5 days
tmax - Time to Maximum Concentration of drug substance in blood plasma
Pharmacokinetics: t 1/2
Time frame: 5 days
Time to metabolism of 1/2 of dose (eg, half-life) of drug substance in blood plasma
Pharmacokinetics: CL/F
Time frame: 5 days
Oral Clearance of the drug substance (CL/F)
Pharmacokinetics: V2/F
Time frame: 5 days
V2/F
Vital Signs: Pulse Rate
Time frame: 5 days
pulse rate measured in beats per minute (bpm). Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Vital signs: Blood Pressure
Time frame: 5 days
Sitting diastolic and systolic blood pressure, measured by Karotkoff Cuff in mmHg. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Vital signs: Respiratory Rate
Time frame: 5 days
Respiratory rate, measured in breaths per minute. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.
Thyroid Test: Trilodothyronine (Free T3)
Time frame: 5 days
Number and percent of patients with clinically significant changes from Baseline in Free T3 (pg/mL), compared across treatment and Placebo groups.
Thyroid Test: Thyroxine (Free T4)
Time frame: 5 days
Number and percent of patients with clinically significant changes from Baseline in Free T4 (ng/dL), compared across treatment and Placebo groups.
Thyroid Test: Thyroid Stimulating Hormone (TSH)
Time frame: 5 days
Number and percent of patients with clinically significant changes from Baseline in TSH (mIU/L), compared across treatment and Placebo groups.
Urinalysis: Urobilinogen
Time frame: 5 days
Number and percent of patients with clinically significant changes from Baseline in Urobilinogen (eu/dL), compared across treatment and Placebo groups.
Urinalysis (Microscopic)
Time frame: 5 days
Number and percent of patients 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.
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 16 Apr 2020.
- 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.
Art Simon, PhD study director
Palm Beach CRO, LLC
Leonard J Dunn, MD principal investigator
Clinical Research of West Florida
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 MyMD1 in people with Undefined, 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 10 inclusion and 16 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 16 Apr 2020. 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. 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: 5 days). The study lists 52 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2020.