Phase I: Safety Studies

Study: Phase Ia Dose-Escalation Safety, Pharmacodynamic and Pharmacokinetic Study of Imprime PGG® Injection

ClinicalTrials.gov Id: NCT00542217

Biothera completed a Phase Ia randomized, double-blind, placebo-controlled, single-dose, dose-escalation study with Imprime PGG® in healthy volunteers.

Study: Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics and Pharmacokinetics Study of Imprime PGG® Injection

ClinicalTrials.gov Id: NCT00542464

Biothera completed a Phase Ib randomized, double-blind, placebo-controlled, multiple-dose (7 day), dose-escalation study with Imprime PGG® in healthy volunteers.

Study: Phase I/II, Randomized, Double-Blind, Study of Progenitor Cell Mobilizing Effects of Imprime PGG® Injection Administered at Varied Dosing Regimens with G-CSF Versus G-CSF Alone

ClinicalTrials.gov Id: NCT00542529

Biothera completed a Phase I/II randomized, double-blind, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of 66 healthy volunteers were enrolled in 2 cohorts and, within each cohort, randomized to 1 of 7 treatment groups receiving Imprime PGG or placebo in varied dosing regimens with granulocyte-colony stimulating factor (G-CSF).