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

NCT05077865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-03-27

No results posted yet for this study

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.

Conditions

  • Hashimoto Disease

Interventions

DRUG

MYMD-1

150 mg capsule

DRUG

Placebo

Matching in appearance to MyMD-1 150mg capsule

Sponsors & Collaborators

  • TNF Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Leonard Dunn, MD · Clinical Research of West Florida, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2021-08-01
Completion
2021-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077865 on ClinicalTrials.gov