Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT06780033
Brief Summary:
This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, study to assess the safety, tolerability, Pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of ART101 administered via subcutaneous injection to hypertensive adult participants. An anticipated 5 dose cohorts (one as optional) with maximum of 40 participants will be randomized in SAD study.
Detailed Description:
The study will be conducted across 5 single ascending dose (SAD) cohorts with approximately 40 participants.
Estimated study duration for each participant: Approximately 13.5 months including a 1.5-month Screening Period, 3-month Treatment Period and up to 12-month Follow-up post dose. On Day 1, participants will receive study drug as a single subcutaneous injection following a minimum 8-hour fast. The planned ART101 dose across 5 cohorts are as follows- 20mg, 60mg, 150mg, 300mg and 500mg. An SRC meeting will be held prior to dose escalations or prior to initiation of next cohort.
Study:
NCT06780033
Study Brief:
Protocol Section:
NCT06780033