NCT07529600

A Phase I Clinical Study of ART101 Injection in Healthy Adult Subjects

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART101 Injection in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Arnatar Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I clinical study, which is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single subcutaneous injection of ART101 injection in healthy adult subjects. This study is planned to include 5 dose groups, with an estimated maximum sample size of approximately 40 subjects. To reduce the safety risk to subjects, a sentinel method will be used in Dose Group 1, where 2 subjects (1 receiving the investigational drug and 1 receiving placebo) will be enrolled first, followed by 6 subjects (5 receiving the investigational drug and 1 receiving placebo). There will be at least a 7-day interval between the administration to the sentinel subjects and the other subjects in Dose Group 1. Subjects in each dose group will receive a single subcutaneous injection of ART101 injection or placebo on Day 1 after at least 8 hours of fasting. Group 1 Single subcutaneous injection 25 mg (N=6) Placebo (N=2) Group 2 Single subcutaneous injection 75 mg (N=6) Placebo (N=2) Group 3 Single subcutaneous injection 150 mg (N=6) Placebo (N=2) Group 4 Single subcutaneous injection 300 mg (N=6) Placebo (N=2) Group 5 (Optional) Single subcutaneous injection ≤600 mg (N=6) Placebo (N=2) The study procedures include a screening period, a treatment period, a follow-up period, and an early termination/study completion follow-up.

Detailed description

The clinical trial was conducted by the Suzhou branch of Suzhou Arnatar Therapeutics Co., Ltd in China.

Conditions

• Hypertension (HTN)

Interventions

Type	Name	Description
DRUG	Subcutaneous (SC) single dose	all administered via subcutaneous injection.

Timeline

• Start date: 2024-01-18
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

2 sites across 1 country: China