Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 12:31 PM
Study NCT ID:
NCT06780033
Status:
TERMINATED
Last Update Posted:
2025-09-22
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate ART101 in Adult Participants With Hypertension
Sponsor:
Arnatar Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ART101 in Adult Participants With Hypertension.
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
At Sponsor's Request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: