A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablets.
Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants, and to determine the recommended dose for Phase II studies (targeting inflammatory bowel diseases like ulcerative colitis).
The trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels (30mg, 100mg, 200-300mg, 600-800mg) are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels (20mg, 50mg, 100-150mg, 300-400mg) are given twice daily for 7 days plus one extra dose on Day 8.
Key procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded.
The trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.