NCT07062185

A Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ENC1018 Capsules in Patients With Moderate-to-severe Active Ulcerative Colitis (UC)

An Open-label, Single-arm, Single-center Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of ENC1018 Capsules in Patients With Moderate-to-severe Active Ulcerative Colitis (UC)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	ENC1018 capsule administration group	ENC1018 capsules were taken orally once a day for 14 days.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-08-01
• Completion: 2026-04-01
• First posted: 2025-07-14
• Last updated: 2025-07-14