This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
For subjects weighing 27-53 kg: 100 mg (1 ml) administered every three weeks by subcutaneous injection. For subjects weighing \> 53 kg: 200 mg (2 ml) administered every three weeks by subcutaneous injection.
Moy, Fincher, and Chipps Facial Plastics and Dermatology
Beverly Hills, California, United States
Meridien Research
St. Petersburg, Florida, United States
Austin Dermatology Associates
Austin, Texas, United States
Safety and tolerability
Incidence and type of adverse clinical events
Time frame: 100 days
RA-18C3 pharmacokinetics
Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.
Time frame: 70 days
Facial acne lesion count
Change in total facial acne lesion count from day 0 to week 8
Time frame: 56 days
Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts
Percent reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts from day 0 to week 8
Time frame: 56 days
Investigator's Global Assessment (IGA) score
Change in Investigator Global Assessment score from baseline to Day 56
Time frame: 56 days
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