Phase I * Study 950170: The first in human study included administration via the subcutaneous route. This study was ended early due to the large number of adverse reactions observed around/in the injection site. * Study 960136: (Dose-escalation). Intended to determine safety and tolerability, biologic activity, and pharmacokinetic profile in 61 healthy volunteers. The study included a single dose as well as a combination of 3 daily doses (ranging from 0.2–20 micrograms/kg) given consecutively. It was determined that single doses did not result in noteworthy production of epithelial cells. * Study 970136 (Randomized, double-blind, placebo-controlled, dose-escalation). Intended to determine the safety and tolerability, and pharmacokinetics of a single dose, administered intravenously (ranging from 5–20 micrograms/kg) in 24 healthy volunteers. It was found that systematic exposure was proportional to the administered dose. Extravascular distribution of the drug was noted. * Study 970290 (Open-label). Intended to evaluate pharmacokinetic properties intersubject variability of the drug in four, healthy male volunteers. It was determined that a high intersubject variability was not the cause of dosing errors in previous studies. * Study 970276 (Dose-escalation). Intended to determine the safety and tolerability, pharmacokinetic and pharmacodynamics properties of the drug versus a placebo in 18 healthy volunteers. The study consisted of daily IV doses in three consecutive days (20 or 40 micrograms/kg). It was determined that subjects that received three daily doses of 40 micrograms/kg demonstrated adequate production of epithelial cells in the buccal mucosa. Predicted elevation in amylase and lipase were also determined. * Study 20010192 (Randomized, double-blind, placebo-controlled, dose-escalation). Intended to determine safety and tolerability, pharmacokinetic and pharmacodynamics properties of the drug versus a placebo by utilization of a single IV dose (ranging from 60 to 250 micrograms/kg) in 84 healthy volunteers. It was determined that after the first 30 minutes (after IV dose was administered) a rapid decline in concentration occurred, followed by a subsequent plateau once 1.5 hours had been achieved. A decline in concentration was consistently observed once 6 hours post-dose had been reached. It was also noted that with a 4X increase in dose, a 3X increase in AUC was achieved. Half-life values of 4–6 hours were noted; extravascular distribution of the drug was noted as well. Phase II * Study 980231 (Randomized, double-blind, placebo-controlled). Three dose regimens were included: "pre-post", "pre", and placebo<unk>  administration (60 micrograms/kg) by IV for three consecutive days before chemotherapy and after autologous peripheral blood progenitor cell (PBPC). Efficacy was demonstrated in the drug versus the placebo. Phase III * Study 2000162 (Randomized, double-blind, placebo-controlled). Intended to evaluate<unk>  efficacy in reducing oral mucositis in subjects with hematologic malignancy undergoing chemotherapy with autologous peripheral blood progenitor cell transplantation. Patients were administered with 3 daily, consecutive IV doses (or placebo) of<unk>  (60 micrograms/kg) before chemotherapy and Filgrastim (60 micrograms/kg) was administered after transplantation for three days consecutively. Efficacy was demonstrated in the drug versus the placebo.
Palifermin
Mecasermin
Tavilermide
Lisocabtagene maraleucel
Safrazine
Povidone-iodine
Cafaminol
Beta-Zearalenol