Study AC-1101-GA-001 is an early phase open-label study with a 4-week treatment and 2-week follow-up period (without treatment) to assess the safety, tolerability, and efficacy of AC-1101 gel in patients with Granuloma Annulare.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
For each patient, once daily (QD)
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
Incidence and proportion of subjects with treatment emergent adverse events (TEAEs), AEs and serious adverse events (SAEs).
Adverse events (AEs), Significant Adverse Events (SAEs), treatment emergent adverse events (TEAEs)
Time frame: Up to 6 weeks
Number of subjects with abnormal vital signs
Vital sign parameters will be analyzed including oral temperature, pulse rate, respiratory rate, and blood pressure.
Time frame: Up to 6 weeks
Number of subjects with abnormal ECG
ECGs will be obtained by using an automated ECG machine to measure PR, QRS, QT, and QTc intervals and calculates heart rate.
Time frame: Up to 6 weeks
Number of subjects with abnormal hematology parameters
Hematology parameters will be analyzed including platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, percent reticulocytes, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Time frame: Up to 6 weeks
Number of subjects with abnormal biochemistry parameters
Biochemistry parameters will be analyzed including blood urea nitrogen (BUN), creatinine, glucose, phosphorus, calcium, phosphate, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, creatine phosphokinase (CPK), total bilirubin, direct bilirubin, total protein, albumin to gloulin ratio, globulin, lipase, and Hemoglobin A1C..
Time frame: Up to 6 weeks
Number of subjects with abnormal urinalysis parameters
Urinalysis parameters will be analyzed including specific gravity, urine creatinine, phosphate and pregnancy test..
Time frame: Up to 6 weeks
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Change in skin irritation using Dermal Rating Scale (DRS)
This is a 0-4 rating with 0 representing the best.
Time frame: Up to 4 weeks
Plasma concentration of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC[0-t]) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to extrapolated to infinity (AUC[0-infinity]) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Maximum observed plasma drug concentration (Cmax) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Time to maximum observed plasma drug concentration (Tmax) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose
Apparent terminal half-life (T1/2) of AC-1101
Blood samples will be collected from patients from Visit 2 to Visit 5
Time frame: Day 1, Day 14, Day 42:Pre-dose; Day 28: Pre-dose, 2 through 24 hours post-dose