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
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
-
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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