NCT05077865

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

A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male and Female Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: TNF Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	MYMD-1	150 mg capsule
DRUG	Placebo	Matching in appearance to MyMD-1 150mg capsule

Timeline

• Start date: 2021-04-26
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2021-10-14
• Last updated: 2023-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study