CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
BIO 300 Oral Powderdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04650555
NCT04650555Phase 1Completed
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A Phase 1 Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profile of BIO 300 Oral Powder in Healthy Volunteers

Humanetics Corporation·interventional·Posted Dec 2, 2020·Updated May 3, 2024

In Brief

A Phase 1 clinical trial evaluating BIO 300 Oral Powder for Acute Radiation Syndrome. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Radiation Syndrome
CountriesUnited States
CollaboratorsUnited States Department of Defense, Joint Warfighter Medical Research Program

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 2, 2020
Enrollment StartDec 8, 2020
Primary CompletionJul 6, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.6 years ago

Interventions

BIO 300 Oral Powderdrug

Amorphous solid dispersion of genistein milled into a powder