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BIO 300 Oral Powder Safety and Pharmacokinetics

NCT04650555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-05-03

Study results available
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Summary

Open-label, single ascending dose and multiple single dose study in healthy volunteers to evaluate the safety and pharmacokinetics of BIO 300 Oral Powder (BIO 300). The single ascending dose study consists of 4 ascending dose cohorts and the multiple single dose study consists of a single dose given daily for 6 consecutive days.

Conditions

  • Acute Radiation Syndrome

Interventions

DRUG

BIO 300 Oral Powder

Amorphous solid dispersion of genistein milled into a powder

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Joint Warfighter Medical Research Program

    collaborator OTHER

  • Humanetics Corporation

    lead INDUSTRY

Principal Investigators

  • Michael D Kaytor, Ph.D. · Humanetics Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2021-07-06
Completion
2021-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04650555 on ClinicalTrials.gov