MedTrace Logo

A Study to Evaluate ART101 in Adult Participants With Hypertension

NCT06780033 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ART-101 - SAD

Forty participants will be enrolled across 5 SAD cohorts. The planned doses across 5 cohorts are as follows- include 20mg (SAD Cohort 1), 60mg (SAD Cohort 2). 150mg (SAD Cohort 3). 300mg (SAD Cohort 4) and 500 mg (SAD Cohort 5).

OTHER

Placebo

Participants will receive matching placebo subcutaneously on Day 1 after 8 hour fast.

Sponsors & Collaborators

  • Arnatar Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780033 on ClinicalTrials.gov