BIO 300 Oral Powder Safety & Pharmacokinetics

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02587442` - A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers	Phase 1
Completed	`NCT00504335` - Safety and Pharmacokinetic Study of BIO 300 Capsules	Phase 1
Completed	`NCT03585803` - A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011	Phase 1
Active, not recruiting	`NCT00903929` - Phase I Study of Eltrombopag for Promoting Thrombopoiesis After Total Body Irradiation	Phase 1

NCT number	NCT04650555
Study type	Interventional
Source	Humanetics Corporation
Contact
Status	Completed
Phase	Phase 1
Start date	December 8, 2020
Completion date	July 6, 2021

BIO 300 Oral Powder Safety and Pharmacokinetics

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms