Last reviewed · How we verify

NCT04650555

BIO 300 Oral Powder Safety and Pharmacokinetics

Completed Phase 1 Results posted Last updated 3 May 2024
What this trial tests

Phase 1 trial testing BIO 300 Oral Powder in Acute Radiation Syndrome in 34 participants. Completed in 6 July 2021.

Timeline
8 December 2020
Primary endpoint
6 July 2021
6 July 2021

Quick facts

Lead sponsorHumanetics Corporation
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment34
Start date8 December 2020
Primary completion6 July 2021
Estimated completion6 July 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Humanetics Corporation — full company profile →

Who can join

Adults 18 to 64, any sex, with Acute Radiation Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adverse Events Related to BIO 300 Oral Powder Primary · Day 1 up to 1 week for Single Ascending Dose and Day 1 up to 2 weeks for Multiple Single Dose

Evaluate the safety of single and multiple dose BIO 300 Oral Powder administration

Dose Limiting Toxicities
GroupValue95% CI
Single Ascending Dose Cohort 20
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 50
Unlikely Treatment-Related Adverse Events
GroupValue95% CI
Single Ascending Dose Cohort 21
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 52
Possibly Treatment-Related Adverse Events
GroupValue95% CI
Single Ascending Dose Cohort 20
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 43
Multiple Single Dose Cohort 57
Probably Treatment-Related Adverse Events
GroupValue95% CI
Single Ascending Dose Cohort 24
Single Ascending Dose Cohort 34
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 515
Definitely Treatment-Related Adverse Events
GroupValue95% CI
Single Ascending Dose Cohort 20
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 42
Multiple Single Dose Cohort 51
Unrelated Adverse Event
GroupValue95% CI
Single Ascending Dose Cohort 20
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 41
Multiple Single Dose Cohort 51
Change in ECG QTc Interval Primary · Day 1 up to 1 week after the last dose for Single Ascending Dose and Multiple Single Dose Cohorts

Measurement of the average QTc interval with Fridericia's correction (completed in triplicate at each timepoint)

Screening
GroupValue95% CI
Single Ascending Dose Cohort 1407± 9.3
Single Ascending Dose Cohort 2402± 19.3
Single Ascending Dose Cohort 3416± 21.8
Single Ascending Dose Cohort 4415± 18.7
Multiple Single Dose Cohort 5413± 13.3
4 Hours Post First Dose
GroupValue95% CI
Single Ascending Dose Cohort 1412± 9.6
Single Ascending Dose Cohort 2407± 16.5
Single Ascending Dose Cohort 3419± 27.8
Single Ascending Dose Cohort 4420± 16.3
Multiple Single Dose Cohort 5417± 7.4
24 Hours Post First Dose
GroupValue95% CI
Single Ascending Dose Cohort 1407± 11.3
Single Ascending Dose Cohort 2400± 11.2
Single Ascending Dose Cohort 3402± 26.7
Single Ascending Dose Cohort 4404± 41.7
Multiple Single Dose Cohort 5413± 9.9
1 Week Post Last Dose
GroupValue95% CI
Single Ascending Dose Cohort 1408± 12.4
Single Ascending Dose Cohort 2401± 18.3
Single Ascending Dose Cohort 3416± 36.3
Single Ascending Dose Cohort 4414± 12.6
Multiple Single Dose Cohort 5415± 9.0
Change in Clinical Laboratory Values Primary · Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose

Monitoring of blood serum levels of albumin and total protein (all reported as g/dL)

Albumin Day 3
GroupValue95% CI
Single Ascending Dose Cohort 14.483± 0.204
Single Ascending Dose Cohort 24.433± 0.393
Single Ascending Dose Cohort 34.333± 0.367
Single Ascending Dose Cohort 44.550± 0.187
Multiple Single Dose Cohort 54.225± 0.349
Albumin Day 6
GroupValue95% CI
Multiple Single Dose Cohort 54.475± 0.249
Albumin Day 7
GroupValue95% CI
Single Ascending Dose Cohort 14.233± 0.216
Single Ascending Dose Cohort 24.283± 0.279
Single Ascending Dose Cohort 34.440± 0.241
Single Ascending Dose Cohort 44.517± 0.117
Albumin Day 13
GroupValue95% CI
Multiple Single Dose Cohort 54.475± 0.306
Total Protein Day 3
GroupValue95% CI
Single Ascending Dose Cohort 16.667± 0.344
Single Ascending Dose Cohort 26.833± 0.638
Single Ascending Dose Cohort 36.500± 0.369
Single Ascending Dose Cohort 46.650± 0.547
Multiple Single Dose Cohort 56.363± 0.444
Total Protein Day 6
GroupValue95% CI
Multiple Single Dose Cohort 56.788± 0.348
Total Protein Day 7
GroupValue95% CI
Single Ascending Dose Cohort 16.417± 0.331
Single Ascending Dose Cohort 26.850± 0.619
Single Ascending Dose Cohort 36.520± 0.438
Single Ascending Dose Cohort 46.717± 0.454
Total Protein Day 13
GroupValue95% CI
Multiple Single Dose Cohort 56.550± 0.518
Change in Clinical Laboratory Values Primary · Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose

Monitoring of blood serum levels of bicarbonate, chloride, potassium, and sodium (all reported as mEq/L)

Bicarbonate Day 3
GroupValue95% CI
Single Ascending Dose Cohort 126.833± 1.722
Single Ascending Dose Cohort 226.167± 0.753
Single Ascending Dose Cohort 327.167± 2.401
Single Ascending Dose Cohort 427.500± 1.049
Multiple Single Dose Cohort 523.875± 2.850
Bicarbonate Day 6
GroupValue95% CI
Multiple Single Dose Cohort 523.750± 1.165
Bicarbonate Day 7
GroupValue95% CI
Single Ascending Dose Cohort 126.500± 1.871
Single Ascending Dose Cohort 227.500± 1.761
Single Ascending Dose Cohort 329.000± 0.707
Single Ascending Dose Cohort 428.667± 1.751
Bicarbonate Day 13
GroupValue95% CI
Multiple Single Dose Cohort 523.125± 1.246
Chloride Day 3
GroupValue95% CI
Single Ascending Dose Cohort 1104.5± 2.429
Single Ascending Dose Cohort 2104.0± 1.549
Single Ascending Dose Cohort 3104.7± 0.816
Single Ascending Dose Cohort 4103.5± 0.837
Multiple Single Dose Cohort 5105.5± 1.927
Chloride Day 6
GroupValue95% CI
Multiple Single Dose Cohort 5103.8± 2.252
Chloride Day 7
GroupValue95% CI
Single Ascending Dose Cohort 1104.3± 1.366
Single Ascending Dose Cohort 2104.5± 1.761
Single Ascending Dose Cohort 3104.2± 1.095
Single Ascending Dose Cohort 4104.8± 2.317
Chloride Day 13
GroupValue95% CI
Multiple Single Dose Cohort 5105.1± 0.835
Change in Clinical Laboratory Values Primary · Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose

Monitoring of blood serum levels of bilirubin (total and direct), BUN, calcium, cholesterol (total), creatinine, HDL, glucose, magnesium, phosphorous, triglycerides, and uric acid (all reported as mg/dL)

Total Bilirubin Day 3
GroupValue95% CI
Single Ascending Dose Cohort 10.467± 0.308
Single Ascending Dose Cohort 20.417± 0.117
Single Ascending Dose Cohort 30.333± 0.137
Single Ascending Dose Cohort 40.650± 0.501
Multiple Single Dose Cohort 50.613± 0.394
Total Bilirubin Day 6
GroupValue95% CI
Multiple Single Dose Cohort 50.500± 0.185
Total Bilirubin Day 7
GroupValue95% CI
Single Ascending Dose Cohort 10.483± 0.331
Single Ascending Dose Cohort 20.583± 0.417
Single Ascending Dose Cohort 30.340± 0.167
Single Ascending Dose Cohort 40.400± 0.141
Total Bilirubin Day 13
GroupValue95% CI
Multiple Single Dose Cohort 50.563± 0.307
Direct Bilirubin Day 3
GroupValue95% CI
Single Ascending Dose Cohort 10.200± 0
Single Ascending Dose Cohort 20.200± 0
Single Ascending Dose Cohort 30.200± 0
Single Ascending Dose Cohort 40.200± 0
Multiple Single Dose Cohort 50.200± 0
Direct Bilirubin Day 6
GroupValue95% CI
Multiple Single Dose Cohort 50.200± 0
Direct Bilirubin Day 7
GroupValue95% CI
Single Ascending Dose Cohort 10.200± 0
Single Ascending Dose Cohort 20.200± 0
Single Ascending Dose Cohort 30.200± 0
Single Ascending Dose Cohort 40.200± 0
Direct Bilirubin Day 13
GroupValue95% CI
Multiple Single Dose Cohort 50.200± 0
Change in Clinical Laboratory Values Primary · Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose

Monitoring of blood serum levels of alkaline phosphatase, ALT, amylase, AST, LDH, and lipase (all reported as IU/L)

ALP Day 3
GroupValue95% CI
Single Ascending Dose Cohort 174.2± 18.1
Single Ascending Dose Cohort 266.7± 13.9
Single Ascending Dose Cohort 364.2± 18.8
Single Ascending Dose Cohort 462.8± 21.4
Multiple Single Dose Cohort 559.5± 15.5
ALP Day 6
GroupValue95% CI
Multiple Single Dose Cohort 560.3± 16.2
ALP Day 7
GroupValue95% CI
Single Ascending Dose Cohort 169.5± 14.7
Single Ascending Dose Cohort 269.0± 17.3
Single Ascending Dose Cohort 368.0± 21.1
Single Ascending Dose Cohort 452.5± 29.7
ALP Day 13
GroupValue95% CI
Multiple Single Dose Cohort 559.4± 18.6
ALT Day 3
GroupValue95% CI
Single Ascending Dose Cohort 118.2± 5.7
Single Ascending Dose Cohort 221.2± 18.6
Single Ascending Dose Cohort 315.2± 3.2
Single Ascending Dose Cohort 416.2± 9.5
Multiple Single Dose Cohort 517.6± 5.5
ALT Day 6
GroupValue95% CI
Multiple Single Dose Cohort 518.4± 4.1
ALT Day 7
GroupValue95% CI
Single Ascending Dose Cohort 116.7± 3.9
Single Ascending Dose Cohort 227.8± 24.1
Single Ascending Dose Cohort 317.8± 6.3
Single Ascending Dose Cohort 416.7± 10.7
ALT Day 13
GroupValue95% CI
Multiple Single Dose Cohort 518.1± 5.1
Area Under Curve of Genistein-Aglycone in Serum Primary · Day 1 for the Single Ascending Dose and Day 6 for the Multiple Single Dose, prior to 1st dose then 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose and Day 1 Multiple Single Dose prior to dosing then 0.5, 1, 2, and 4 hours post dose

Area under the curve of BIO 300 Oral Powder as assessed by analyzing serum concentrations of genistein-aglycone (free genistein) at multiple timepoints

GroupValue95% CI
Single Ascending Dose Cohort 1902.9± 605.1
Single Ascending Dose Cohort 21530.9± 518.2
Single Ascending Dose Cohort 31730.8± 361.6
Single Ascending Dose Cohort 45836.0± 3280.8
Multiple Single Dose Cohort 52957.3± 1222.4
Number of Differentially Expressed Genes From Whole Blood Samples Secondary · Day 1 for the Single Ascending Dose prior to dosing then 1, 2, 4, and 24 hours post dose and Day 1 Multiple Single Dose prior to dosing then 1, 2, and 4 hours post dose and and Day 6 prior to dosing then 4, 8, 12 and 24 hours post dose

The number of significantly differentially expressed genes detected in whole blood samples at various timepoints after BIO 300 Oral Powder dosing. Significant differential gene expression was defined as genes that have a mean absolute log2 fold change \>2 with an adjusted p-value of \<0.05 relative to baseline expression levels.

Day 1, 1 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 50
Day 1, 2 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 50
Day 1, 4 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 31
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 50
Day 1, 24 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 50
Day 6, 4 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 50
Day 6, 8 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 56
Day 6, 12 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 57
Day 6, 24 hr post-dose
GroupValue95% CI
Single Ascending Dose Cohort 10
Single Ascending Dose Cohort 30
Single Ascending Dose Cohort 40
Multiple Single Dose Cohort 50

Adverse events — posted to ClinicalTrials.gov

Time frame: Screening to 1 week after the last dose of BIO 300 Oral Powder (up to 5 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Ascending Dose Cohort 1
Serious: 0/6 (0%)
Deaths: 0/6
Single Ascending Dose Cohort 2
Serious: 0/6 (0%)
Deaths: 0/6
Single Ascending Dose Cohort 3
Serious: 0/6 (0%)
Deaths: 0/6
Single Ascending Dose Cohort 4
Serious: 0/6 (0%)
Deaths: 0/6
Multiple Single Dose Cohort 5
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (16 terms — click to expand)

ReactionSystemSingle Ascending Dose Coho…Single Ascending Dose Coho…Single Ascending Dose Coho…Single Ascending Dose Coho…Multiple Single Dose Cohor…
DiarrheaGastrointestinal disorders—————
HeadacheNervous system disorders—————
FatigueGeneral disorders—————
ConstipationGastrointestinal disorders—————
NauseaGastrointestinal disorders—————
MyalgiaMusculoskeletal and connective tissue disorders—————
PalpitationsCardiac disorders—————
Abdominal PainGastrointestinal disorders—————
BloatingGastrointestinal disorders—————
FlatulenceGastrointestinal disorders—————
VomitingGastrointestinal disorders—————
Lipase IncreasedInvestigations—————
AnorexiaMetabolism and nutrition disorders—————
LightheadedNervous system disorders—————
Perioral ParesthesiaNervous system disorders—————
Nasal CongestionRespiratory, thoracic and mediastinal disorders—————

Data from ClinicalTrials.gov NCT04650555 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Radiation emergency medical countermeasures: Current formulary, identified gaps, and future approaches.
    Ma WB, Yin RH, Ren GM, Zhang Y, et al · · 2025 · cited 2× · PMID 41229308 · DOI 10.1002/ame2.70109

Verify or expand the search:

Other Humanetics Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04650555.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing