This is an open-label, single-arm, single-center study to evaluate the safety, pharmacokinetics, and efficacy signal of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC).
The study will enroll about 10 diagnosed patients with moderate-to-severe active UC. Each patient will receive an oral dose of ENC1018 capsules once daily for 14 consecutive days after enrollment. Before each dose, patients must fast for at least 2 hours to remain in a fasting state, and no food should be consumed for at least 2 hours after dosing. The entire study period includes a screening phase of up to 3 weeks, a 14-day treatment period, and a 2-week follow-up period. The total duration of the trial is up to 49 days, and patients will be hospitalized during the treatment period. Blood and fecal samples will be collected during the study for PK evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
ENC1018 capsules were taken orally once a day for 14 days.
Adverse events (AE) and Serious Adverse Events (SAE);
Time frame: Day 1 - Day 28
Tmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Time frame: Day 1 - Day 17
Cmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Time frame: Day 1 - Day 17
AUC of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Time frame: Day 1 - Day 17
Fecal PK parameters of ENC1018 and its major metabolites: cumulative excretion amount (Ae);
Time frame: Day 1- Day 17
Changes in partial Mayo scores (excluding endoscopy scores from the complete modified Mayo score) from baseline;
Time frame: Day 1- Day 28
Changes in the pharmacodynamic biomarker hsCRP and fecal calcarein from baseline.
Time frame: Day 1- Day 28
Fecal PK parameters of ENC1018 and its major metabolites: excretion fraction (Fe);
Time frame: Day 1- Day 17
Changes in defecation frequency (SF) scores from baseline;
Time frame: Day 1- Day 28
Changes in blood in the stool (RB) scores from baseline;
Time frame: Day 1- Day 28
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