scholarly journals A 6-week repeated intranasal dose toxicity study of TTA-121, a novel oxytocin nasal spray, in cynomolgus monkeys

2019 ◽  
Vol 6 (7) ◽  
pp. 269-275 ◽  
Author(s):  
Emi Matsumoto ◽  
Junichi Namekawa ◽  
Hideshi Kaneko ◽  
Takasumi Shimomoto ◽  
Mitsuaki Masuyama ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Toxicity Study ◽  
Cynomolgus Monkeys ◽  
Intranasal Dose

scholarly journals A 6-week repeated intranasal dose toxicity study of TTA-121, a novel oxytocin nasal spray, in rats

2019 ◽  
Vol 6 (7) ◽  
pp. 259-268 ◽  
Author(s):  
Junichi Namekawa ◽  
Emi Matsumoto ◽  
Hideshi Kaneko ◽  
Takasumi Shimomoto ◽  
Takayuki Okamura ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Toxicity Study ◽  
Intranasal Dose

30-day oral toxicity study of domoic acid in Cynomolgus monkeys: Lack of overt toxicity at doses approaching the acute toxic dose

10.1002/nt.5 ◽  
1997 ◽  
Vol 5 (3) ◽  
pp. 111-114 ◽  
Author(s):  
John Truelove ◽  
Rudi Mueller ◽  
Olga Pulido ◽  
Leigh Martin ◽  
Susan Fernie ◽  
...  
Keyword(s):  
Domoic Acid ◽  
Toxicity Study ◽  
Oral Toxicity ◽  
Toxic Dose ◽  
Cynomolgus Monkeys ◽  
Acute Toxic

scholarly journals Effects of tanezumab on satellite glial cells in the cervicothoracic ganglion of cynomolgus monkeys: A 26-week toxicity study followed by an 8-week recovery period

2019 ◽  
Vol 218 ◽  
pp. 51-53
Author(s):  
Mark Evans ◽  
Mark Butt ◽  
Patrice Belanger ◽  
Thomas Cummings ◽  
Jessica-lyn Gremminger ◽  
...  
Keyword(s):  
Glial Cells ◽  
Recovery Period ◽  
Toxicity Study ◽  
Satellite Glial Cells ◽  
Cynomolgus Monkeys

30-day oral toxicity study of domoic acid in Cynomolgus monkeys: Lack of overt toxicity at doses approaching the acute toxic dose

1998 ◽  
Vol 5 (3) ◽  
pp. 111-114
Author(s):  
John Truelove ◽  
Rudi Mueller ◽  
Olga Pulido ◽  
Leigh Martin ◽  
Susan Fernie ◽  
...  
Keyword(s):  
Domoic Acid ◽  
Toxicity Study ◽  
Oral Toxicity ◽  
Toxic Dose ◽  
Cynomolgus Monkeys ◽  
Acute Toxic

13-Week Inhalation Toxicity Study of Dimethylformamide (DMF) in Cynomolgus Monkeys

1992 ◽  
Vol 18 (4) ◽  
pp. 596-601 ◽  
Author(s):  
M. E. HURTT ◽  
M. E. PLACKE ◽  
J. M. KILLINGER ◽  
A. W. SINGER ◽  
G. L. KENNEDY
Keyword(s):  
Toxicity Study ◽  
Inhalation Toxicity ◽  
Cynomolgus Monkeys

A 39-week oral toxicity study of ulipristal acetate in cynomolgus monkeys

2013 ◽  
Vol 66 (1) ◽  
pp. 6-12 ◽  
Author(s):  
Oliver Pohl ◽  
Alistair R.W. Williams ◽  
Christine Bergeron ◽  
Jean-Pierre Gotteland
Keyword(s):  
Toxicity Study ◽  
Oral Toxicity ◽  
Cynomolgus Monkeys ◽  
Ulipristal Acetate

Preclinical Safety of Baxter's Recombinant ADAMTS13

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3381-3381 ◽  
Author(s):  
Christina Piskernik ◽  
Barbara Dietrich ◽  
Susan Kubik ◽  
Tanja Ruthsatz ◽  
Friedrich Scheiflinger ◽  
...  
Keyword(s):  
Microvascular Disease ◽  
Toxicity Study ◽  
Repeat Dose ◽  
Case Scenario ◽  
Worst Case ◽  
Local Tolerance ◽  
Cynomolgus Monkeys ◽  
Repeat Dose Toxicity

Abstract Abstract 3381 Baxter is currently developing a recombinant ADAMTS13 (rADAMTS13, a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) product for treatment, and routine prophylaxis of acute episodes of thrombotic thrombocytopenic purpura (TTP) in patients with ADAMTS13 deficiency. TTP is a rare, life-threatening microvascular disease characterized by single or recurrent episodes of thrombocytopenia, microangiopathic haemolytic anaemia and widespread microvascular thrombosis, which leads to the ischemic damage of multiple organs. To characterize the safety and the no observed adverse effect level (NOAEL) of Baxter's rADAMTS13, a 1-month repeat dose toxicity study in rats, an escalating dose and pilot 4-week repeat dose toxicity study in cynomolgus monkeys, and a 1-month repeat dose toxicity study including cardiovascular/pulmonary safety pharmacology in cynomolgus monkeys was conducted. Species suitability was shown by demonstrating that human rADAMTS13 can cleave monkey and rat VWF in vitro and in vivo under native conditions to present a worst case scenario for repeat dose toxicity studies. A local tolerance study was conducted in rabbits. Baxter's rADAMTS13 was well tolerated in rats at doses of 80, 400 and 800 FRETS-U/kg administered every third day for one month. Thus, the NOAEL in rats was the highest dose of 800 FRETS-U/kg. In cynomolgus monkeys, no adverse effects were detected at 800 FRETS-U/kg after intravenous treatment with rADAMTS13 once a week for 5 weeks (pilot repeat dose study). The NOAEL for the escalating dose phase of the study was 1790 FRETS-U/kg. Treatment of cynomolgus monkeys with bolus injection of Baxter's rADAMTS13 at doses of 80, 200, and 400 FRETS-U/kg once a week for 29 days did not reveal adverse findings. Thus, the NOAEL for this study was the highest dose of 400 FRETS-U/kg. As expected for a heterologous human protein drug, repeat doses of rADAMTS13 resulted in the formation of anti-drug antibodies specific for human ADAMTS13 and in neutralising human ADAMTS13 activity in animal models. No injection site reactions were observed in animals of either species. rADAMTS13 was well tolerated after intravenous (intended clinical administration route), intraarterial and paravenous administration in rabbits. In conclusion, Baxter's rADAMTS13 was well tolerated in rats, monkeys and rabbits, with no toxicity observed even at the highest dose levels. Disclosures: Piskernik: Baxter Innovations GmbH: Employment. Dietrich:Baxter Innovations GmbH: Employment. Kubik:Baxter Innovations GmbH: Employment. Ruthsatz:Baxter Innovations GmbH: Employment. Scheiflinger:Baxter Innovations GmbH: Employment. Schwarz:Baxter Innovations GmbH: Employment. Muchitsch:Baxter Innovations GmbH: Employment.

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