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A Phase Ⅰ b Clinical Study of ART101 Injection

NCT07614308 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-29

No results posted yet for this study

Summary

This is an open-label, single dose Phase Ib clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of a single subcutaneous injection of ART101 in patients with hypertension.

The study plans to include 2 dose groups: ART101 600 mg and 800 mg. It is planned to enroll 8 subjects per group, for a total of 16 subjects.

For dose escalation, a Safety Review Committee (SRC) will be established. If a dose group meets the dose escalation termination criteria, or if significant safety events occur during the dose escalation observation period (within 30 days), the SRC will discuss with the sponsor to decide whether to continue the dose escalation.

The screening period for this study is ≤6 weeks. After fasting for at least 8 hours, subjects will receive a single subcutaneous injection of ART101 on Day 1 (D1). The treatment observation period is 24 weeks. At the end of the 24-week treatment observation period, if the subject's angiotensinogen level has not recovered to more than 50% of the baseline level, the follow-up period will be extended. Subjects will continue to receive visits every 12 weeks until the angiotensinogen level recovers to more than 50% of the baseline level, or until 48 weeks after administration of the investigational drug, whichever occurs first.

Conditions

  • Hypertension (HTN)

Interventions

DRUG

ART101 injection

All participants will receive single subcutaneously of ART101 injection on day 1 .

Sponsors & Collaborators

  • Arnatar Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ruihua Dong · Beijing Friendship Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2026-10-14
Completion
2026-11-30

Countries

  • China

Study Locations

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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 NCT07614308 on ClinicalTrials.gov