Status:
COMPLETED
Single Ascending-dose Study to Evaluate Safety, Tolerability, and PK of MYMD1 in Healthy Male Adult Subjects
Lead Sponsor:
TNF Pharmaceuticals, Inc.
Conditions:
Undefined
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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...
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 healt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04349761
Start Date
June 11 2019
End Date
December 30 2019
Last Update
April 16 2020
Active Locations (1)
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1
Palm Beach CRO, LLC
West Palm Beach, Florida, United States, 33409