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

Hashimoto Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05077865
Study type Interventional
Source MyMD Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date April 26, 2021
Completion date August 1, 2021
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