Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following administration of single subcutaneous doses in healthy subjects.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic
profile of single-ascending doses of CC-90006 in healthy subjects.
This will be a placebo-controlled, single-ascending dose study of CC-90006. Approximately 40
subjects will be enrolled. Five dose levels are planned. Each dose level will enroll 8
subjects who will be assigned randomly to receive active CC-90006 (6 subjects) and placebo (2
subjects).
Eligible subjects will check into the clinic site on the day before dosing (Day -1) and
receive the assigned dose by subcutaneous injection the following day (Day 1). Subjects will
be discharged from the site on Day 4 and return for visits on Days 8 (week 1), 15 (week 2),
22 (week 3), 29 (week 4), 36 (week 5), 43 (week 6), 57 (week 8), and 71 (week 10). Subjects
will also be followed up via a phone call on Day 105 (week 15). Safety assessments will be
performed and blood samples will be collected for determination of levels of CC-90006 in the
blood.
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