The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx when given at increasing single doses and to assess the safety and tolerability of the same doses when given multiple times.
To evaluate the safety and tolerability of a single subcutaneous injection of ISIS-SGLT2Rx administered at four increasing dose levels (50, 100, 200, 400 mg) and to evaluate the safety and tolerability of multiple doses of ISIS 388626 administered subcutaneously of either 6 or 13 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg Placebo: 0.9% sterile saline
Center for Human Drug Research
Leiden, Netherlands
To evaluate the safety and tolerability of single and multiple doses of ISIS-SGLT2Rx administered subcutaneously
Time frame: 30 days for single dose, 11 weeks for 6-week dosing, 18 weeks for 13-week dosing
Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups
Time frame: 3 days for single dose, 11 weeks for 6-week dosing, 18 weeks for 13-week dosing
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