Randomized, Double‑Blind, Placebo‑Controlled Dose‑Escalation Study of GRT‑001 Assessing Safety, Tolerability, PK/PD in Healthy Subjects for Ulcerative Colitis

Primary objective is to assess the safety, tolerability, and pharmacokinetic/pharmacodynamic profiles of GRT-001 after subcutaneous administration in healthy volunteers, thereby informing dose selection for future trials in ulcerative colitis.

The sponsor did not provide the total number of participants. The trial enrolled both female and male individuals classified as healthy volunteers. The age range of the enrolled cohort was not specified in the available data. Participants were selected without reference to specific lifestyle factors such as diet, physical activity, or other habits, as these details were not disclosed. No explicit inclusion or exclusion criteria were described beyond the designation of healthy status.

The study is a randomized, double-blind, placebo-controlled dose‑escalation trial (Phase 3) evaluating the safety, tolerability, and pharmacokinetics/pharmacodynamics of GRT‑001 administered subcutaneously in healthy volunteers; the investigational product is intended for ulcerative colitis. The schedule begins with a screening visit to determine eligibility, followed by a baseline visit on Day 0 when the initial dose is given. Subsequent follow‑up visits occur at predefined intervals to collect safety laboratory data, vital signs, and drug concentration measurements, with dose escalation decisions made after interim safety review. The trial concludes with an end‑of‑study visit after the final dose, and participant involvement spans approximately ten months, aligning with the overall study period from April 2026 to February 2027.

Efficacy will be evaluated using protocol‑specified criteria appropriate for ulcerative colitis. Assessments will be performed at predefined study visits and analyzed according to the statistical analysis plan.