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

NCT ID: NCT04349761

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2019-12-30

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.

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

Study Design

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

Study Groups

Cohort 1 - 5mg MyMD1

8 subjects randomized to receive either 5mg MyMD1 (6 subjects) or Placebo (2 subjects)

Group Type: EXPERIMENTAL

MyMD1

Intervention Type: DRUG

Isomyosamine 5mg capsules

Placebo

Intervention Type: DRUG

Placebo

Cohort 2 - 10mg MyMD1

8 subjects randomized to receive either 10mg MyMD1 (6 subjects) or Placebo (2 subjects)

Group Type: EXPERIMENTAL

MyMD1

Intervention Type: DRUG

Isomyosamine 5mg capsules

Placebo

Intervention Type: DRUG

Placebo

Cohort 3 - 15mg MyMD1

8 subjects randomized to receive either 15mg MyMD1 (6 subjects) or Placebo (2 subjects)

Group Type: EXPERIMENTAL

MyMD1

Intervention Type: DRUG

Isomyosamine 5mg capsules

Placebo

Intervention Type: DRUG

Placebo

Cohort 4 - 20mg MyMD1

8 subjects randomized to receive either 20mg MyMD1 (6 subjects) or Placebo (2 subjects)

Group Type: EXPERIMENTAL

MyMD1

Intervention Type: DRUG

Isomyosamine 5mg capsules

Placebo

Intervention Type: DRUG

Placebo

Cohort 5 - 25mg MyMD1 or Placebo

8 subjects randomized to receive either 25mg MyMD1 (6 subjects) or Placebo (2 subjects)

Group Type: EXPERIMENTAL

MyMD1

Intervention Type: DRUG

Isomyosamine 5mg capsules

Placebo

Intervention Type: DRUG

Placebo

Interventions

MyMD1

Isomyosamine 5mg capsules

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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.

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

Sponsors

TNF Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Art Simon, PhD

Role: STUDY_DIRECTOR

Palm Beach CRO, LLC

Leonard J Dunn, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research of West Florida

Locations

Palm Beach CRO, LLC

West Palm Beach, Florida, United States

Countries

United States

Other Identifiers

MyMD-PK-001

Identifier Type: -

Identifier Source: org_study_id