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. Author manuscript; available in PMC: 2017 Apr 1.
Published in final edited form as: Invest New Drugs. 2016 Jan 4;34(2):149–158. doi: 10.1007/s10637-015-0318-3

Table 3.

The summary of the TOX-2013-002 preclinical D2C7-IT toxicity trial

Group Cohort** D2C7-IT
Total
Dose (µg)
in 3 days		 No. of Animals No. of rats showing
abnormal clinical signs
(Total No. from both cohorts)		 No. of unscheduled
mortality
(Total No. from both cohorts)
Control* Acute 0 10 (5 males, 5 females) 13 (7 males, 6 females) 4 (3 males, 1 female)
Chronic 10 (5 males, 5 females)
D2C7-IT
Low
Dose		 Acute 0.075 10 (5 males, 5 females) 17 (10 males, 7 females) 4 (3 males, 1 female)
Chronic 10 (5 males, 5 females)
D2C7-IT
Median
Dose		 Acute 0.15 10 (5 males, 5 females) 14 (7 males, 7 females) 3 (2 males, 1 female)
Chronic 10 (5 males, 5 females)
D2C7-IT
High
Dose		 Acute 0.3 10 (5 males, 5 females) 14 (7 males, 7 females) 3 (1 male, 2 females)
Chronic 10 (5 males, 5 females)
*

Control formulation: Sodium phosphates buffer in saline, 3% HSA, 2 µCi 124I-HSA, and 1 mM Gd-DTPA

**

The TOX-2013-002 trial was terminated after 10 days of the in-life portion of the trial.