A Study of ART105 in Healthy Adult Participants

A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART105 in Healthy Adult Participants

The goal of this clinical trial is to learn if ART105 is safe in healthy adult participants. It will also learn about the PK and PD profiles of ART105. The main questions it aims to answer are:

Is ART105 safe and tolerable in adult participants? How does the ART105 influence the urine PC1 level of participants?

Participants will:

recieve single dose of ART105 and visit the clinic 3 months

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: ART105

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Voluntary participation with signed written informed consent (ICF) .
2. Male or female, aged 18-55 years (inclusive).
3. males ≥ 50 kg; females ≥ 45 kg; and BMI between 19 and 26 kg/m² (inclusive).
4. No history of clinically significant abnormalities.
5. Normal or not clinically significant (NCS) findings at screening for vital signs, physical exam, lab tests, 12-lead ECG, and abdominal ultrasound.
6. Participants of childbearing potential (or males with partners of childbearing potential) must agree to use highly effective contraception.

Exclusion Criteria:

1. Any uncontrolled or severe disease, or any medical or surgical condition that may interfere with the participant's participation in the clinical trial
2. History of hypersensitivity to oligonucleotide drugs, or known hypersensitivity to the investigational product or any of its excipients
3. Use of any ASO or siRNA drugs within 12 months prior to the first dose
4. History of alcohol abuse
5. History of drug or substance abuse, or a positive urine drug abuse screening test
6. Major surgery within 3 months prior to the administration of the investigational product or planned elective surgery during the study period.
7. Use of any prescription medications, over-the-counter (OTC) drugs, or herbal medicines within 14 days prior to the administration of the investigational product, or within 5 half-lives of the drug (whichever is longer).
8. Enrollment in or ongoing participation in any other clinical trial within 3 months or 5 half-lives (whichever is longer) prior to the administration of the investigational product
9. Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), or Treponema pallidum antibody (syphilis).
10. Occurrence of acute illness or use of concomitant medications from the screening phase until prior to the administration of the investigational product.
11. Consumption of any alcohol-containing products or a positive breath alcohol test within 48 hours prior to the administration of the investigational product.
12. Participants who, in the investigator's opinion, have other factors that make them unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: first dose level; ART105 OR Placebo	Drug: Placebo; injection; Drug: ART105; injection
Experimental: second dose level; ART105 OR Placebo	Drug: Placebo; injection; Drug: ART105; injection
Experimental: third dose level; ART105 OR Placebo	Drug: Placebo; injection; Drug: ART105; injection
Experimental: fourth dose level; ART105 OR Placebo	Drug: Placebo; injection; Drug: ART105; injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma maximum observed concentration (Cmax) of ART105		Baseline to Day 3
Plasma time to maximum observed concentration (Tmax) of ART105		Baseline to Day 3
Plasma half-life (t½) of ART105		Baseline to Day 3
Plasma area under the concentration-time curve up to 24 hr post dose (AUC0-24) of ART105		Baseline to Day 3
Fraction of ART105 excreted in the urine (fe)		Baseline to Day 3
Total amount of ART105 excreted in the urine (Ae)		Baseline to Day 3
PD biomarkers change	Changes from baseline in urine PC1 and PC2 levels	Baseline to Day 85

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of neutrophil gelatinase-associated lipocalin (NGAL) in urine		Baseline to Day 29
Concentration of kidney injury molecule-1 (KIM-1) in urine		Baseline to Day 29
Incidence of ADA	Incidence of ADA with NAb testing for ADA-positive samples if necessary	Baseline to Day 85

Collaborators and Investigators

• Sponsor: Arnatar Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027

Study Registration Dates

• First Submitted: July 25, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 5, 2026

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ART105-CN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No