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

NCT05077865 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MyMD-PK-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hashimoto Disease

Outcome Measures

Primary Outcomes (35)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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 %.

  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.

  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.

  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.

  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).

  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.

  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.

  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"

  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)

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

Study Arms (8)

Cohort 1 - Active

EXPERIMENTAL

6 subjects, randomized to receive 150mg MYMD1 (Isomyosamine), administered as one 150mg capsule on Day 1.

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.

Drug: Placebo

Cohort 2 - Active

EXPERIMENTAL

6 subjects, randomized to receive 300mg MYMD1 (Isomyosamine), administered as two 150mg capsules on Day 1.

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.

Drug: Placebo

Cohort 3 - Active

EXPERIMENTAL

6 subjects, randomized to receive 450mg MYMD1 (Isomyosamine), administered as three 150mg capsules on Day 1.

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.

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.

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.

Drug: Placebo

Interventions

MYMD-1 DRUG

150 mg capsule

Also known as: Isomyosamine

Cohort 1 - Active; Cohort 2 - Active; Cohort 3 - Active; Cohort 4 - Active

Placebo DRUG

Matching in appearance to MyMD-1 150mg capsule

Cohort 1 - Placebo; Cohort 2 - Placebo; Cohort 3 - Placebo; Cohort 4 - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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 -

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TNF Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Research of West Florida, Inc

Clearwater, Florida, 33765, United States

Location

MeSH Terms

Conditions

Hashimoto Disease

Interventions

isomyosmine

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Leonard Dunn, MD

  Clinical Research of West Florida, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo is matching in appearance to the 150mg MYMD1 capsules
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled study

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: April 26, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)