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

NCT ID: NCT05077865

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2021-08-01

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.

Detailed Description

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

Conditions

Hashimoto Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1 - Active

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

Group Type: EXPERIMENTAL

MYMD-1

Intervention Type: DRUG

150 mg capsule

Cohort 1 - Placebo

2 subjects, randomized to receive placebo, administered on Day 1, as one capsule matching the 150mg MYMD1 capsule in appearance.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching in appearance to MyMD-1 150mg capsule

Cohort 2 - Active

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

Group Type: EXPERIMENTAL

MYMD-1

Intervention Type: DRUG

150 mg capsule

Cohort 2 - Placebo

2 subjects, randomized to receive placebo, administered on Day 1, as two capsules matching the 150mg MYMD1 capsules in appearance.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching in appearance to MyMD-1 150mg capsule

Cohort 3 - Active

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

Group Type: EXPERIMENTAL

MYMD-1

Intervention Type: DRUG

150 mg capsule

Cohort 3 - Placebo

2 subjects, randomized to receive placebo, administered on Day 1, as three capsules matching the 150mg MYMD1 capsules in appearance.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching in appearance to MyMD-1 150mg capsule

Cohort 4 - Active

6 subjects, randomized to receive 600mg MYMD1 (Isomyosamine), administered as four 150mg capsules each on Days 1, 2, 3, 4, and 5.

Group Type: EXPERIMENTAL

MYMD-1

Intervention Type: DRUG

150 mg capsule

Cohort 4 - Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching in appearance to MyMD-1 150mg capsule

Interventions

MYMD-1

150 mg capsule

Intervention Type: DRUG

Placebo

Matching in appearance to MyMD-1 150mg capsule

Intervention Type: DRUG

Other Intervention Names

Isomyosamine

Eligibility Criteria

Inclusion Criteria

1. Provide written ICF.

2. Is a male or female aged 18 to 65 years.

3. 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.

4. Body mass index of 18 to 31 kg/m2, inclusive.

5. Have estimated glomerular filtration rate (mL/min/1.73m2) or estimated creatinine clearance ≥90 mL.

6. 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).

7. Have adequate peripheral venous access.

8. Test negative for human immunodeficiency virus, hepatitis C virus antibodies, and hepatitis B surface antigen.

9. Test negative for drugs of abuse, including oxycodone, tricyclic anti-depressants, methadone, opiates, marijuana, phencyclidines, barbiturates, methamphetamine, ecstasy, amphetamine, cocaine, and benzodiazepine.

10. Be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and study center staff.

11. Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception -

Exclusion Criteria

1. Have an allergy to any of the study treatment ingredients.

2. Are unable to swallow capsules.

3. Have an elective medical procedure scheduled during the study. Bariatric surgery is also excluded.

4. Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study.

5. Have any history of seizure disorder that has required medical treatment after 18 years of age.

6. Current smoker or smokeless tobacco user, ie, no use of tobacco within 30 days of study entry.

7. Have participated in any drug or medical device-related clinical study within 30 days of study entry.

8. 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).

9. 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.

10. On ECG, QTcF >450 ms or the presence of clinically significant abnormalities as determined by the Investigator (Screening or Day -1).

11. 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.

12. Have gastrointestinal malabsorption.

13. 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.

14. 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.

15. 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.

16. Donation of blood or any blood product within 56 days of Day 1.

17. Willing to use effective contraception as in from Day -1 until 90 days after receiving study treatment.

18. Once it is confirmed that the subject meets eligibility for check-in, the subject will return approximately 5 to 7 days prior to their scheduled Day -1 to complete a COVID-19 test. All subjects will be required to have a negative test prior to check-in. A positive test will result in exclusion from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TNF Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard Dunn, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research of West Florida, Inc

Locations

Clinical Research of West Florida, Inc

Clearwater, Florida, United States

Countries

United States

Other Identifiers

MyMD-PK-002

Identifier Type: -

Identifier Source: org_study_id