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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349761
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
MyMD Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Undefined Drug: MyMD1 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, single ascending dose study.
Masking: Double (Participant, Investigator)
Masking Description: Placebo is identical in appearance to IP
Primary Purpose: Other
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
Actual Study Start Date : June 11, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 - 5mg MyMD1
8 subjects randomized to receive either 5mg MyMD1 (6 subjects) or Placebo (2 subjects)
Drug: MyMD1
Isomyosamine 5mg capsules

Drug: Placebo
Placebo

Experimental: Cohort 2 - 10mg MyMD1
8 subjects randomized to receive either 10mg MyMD1 (6 subjects) or Placebo (2 subjects)
Drug: MyMD1
Isomyosamine 5mg capsules

Drug: Placebo
Placebo

Experimental: Cohort 3 - 15mg MyMD1
8 subjects randomized to receive either 15mg MyMD1 (6 subjects) or Placebo (2 subjects)
Drug: MyMD1
Isomyosamine 5mg capsules

Drug: Placebo
Placebo

Experimental: Cohort 4 - 20mg MyMD1
8 subjects randomized to receive either 20mg MyMD1 (6 subjects) or Placebo (2 subjects)
Drug: MyMD1
Isomyosamine 5mg capsules

Drug: Placebo
Placebo

Experimental: Cohort 5 - 25mg MyMD1 or Placebo
8 subjects randomized to receive either 25mg MyMD1 (6 subjects) or Placebo (2 subjects)
Drug: MyMD1
Isomyosamine 5mg capsules

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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 .

  2. 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.

  3. Variation of MyMD1 concentration in blood plasma as a function of time [ Time Frame: 5 days ]
    AUC (0-inf)

  4. 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.

  5. 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.


  6. 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.


  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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 %.

  20. 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 %.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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).

  28. 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).

  29. 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.

  30. 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.

  31. 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"

  32. 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)

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. Changes in Physical examination: Height [ Time Frame: 5 days ]
    Height (cm) measured using ruler attached to weighing scale.

  39. 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

  40. Pharmacokinetics: Cmax [ Time Frame: 5 days ]
    Cmax - Maximum Concentration of drug substance in blood plasma

  41. Pharmacokinetics: tmax [ Time Frame: 5 days ]
    tmax - Time to Maximum Concentration of drug substance in blood plasma

  42. 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

  43. Pharmacokinetics: CL/F [ Time Frame: 5 days ]
    Oral Clearance of the drug substance (CL/F)

  44. Pharmacokinetics: V2/F [ Time Frame: 5 days ]
    V2/F

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. 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.


Other Outcome Measures:
  1. Biomarker assessment: TNF alpha [ Time Frame: 5 days ]
    Tissue Necrosis Factor (TNF) alpha

  2. Biomarker assessment: thyroglobulin [ Time Frame: 5 days ]
    thyroglobulin (IU/mL)

  3. Biomarker assessment: TPO antibodies [ Time Frame: 5 days ]
    thyroperoxidase (TPO) antibodies

  4. Biomarker assessment [ Time Frame: 5 days ]
    pyridyloxobutyl (POB) adducts in hemophilia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written Informed Consent.
  • Stable medical history and general health.
  • Body weight between 60 - 100 kg and Body Mass Index (BMI) of 18-31 kg/m2.
  • Estimated GFR (eGFR) - mL/min/1.73m2 or estimated creatinine clearance (CLcr) (mL) ≥90.
  • Normal hepatic function.
  • Adequate peripheral venous access.
  • Test negative for HIV, hepatitis C virus antibodies, and hepatitis B surface antigen (HBsAg).
  • Test negative for drugs of abuse.
  • Willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and study center staff.
  • Willing to use effective contraception from Day -1 until 90 days after receiving study medication.

Exclusion Criteria:

  • Allergy to any product ingredients.
  • Unable to swallow capsules.
  • Elective medical procedure during study.
  • Abusing drugs or alcohol and/or history of drug or alcohol dependence within 6 months of study entry.
  • History of seizure disorder requiring medical treatment after 18 years of age.
  • Current smoker or smokeless tobacco user.
  • Participation in drug or medical device clinical study within 30 days of study. entry or 5 times half-life of study drug, whichever is longer.
  • Medically significant standard clinical laboratory assessments.
  • Significant medical condition which might interfere with the study or put subject at significant risk.
  • QTcF >450 ms or clinically significant ECG abnormalities.
  • Elevation of blood pressure (BP) - Supine BP >145mmHg; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349761


Locations
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United States, Florida
Palm Beach CRO, LLC
West Palm Beach, Florida, United States, 33409
Sponsors and Collaborators
MyMD Pharmaceuticals, Inc.
Investigators
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Study Director: Art Simon, PhD Palm Beach CRO, LLC
Principal Investigator: Leonard J Dunn, MD Clinical Research of West Florida
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Responsible Party: MyMD Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04349761    
Other Study ID Numbers: MyMD-PK-001
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MyMD Pharmaceuticals, Inc.:
Pharmacokinetics
Phase I
First-in-Human
Safety
Tolerability
Hashimoto thyroiditis
Autoimmune