A Study of ART105 in Healthy Adult Participants

NCT07748026 | Not Yet Recruiting Phase 1

• 1 other identifier: ART105-CN-01
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs

  Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline to Day 85

Secondary Outcomes (7)

• 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

Other Outcomes (3)

• 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

  Baseline to Day 85

Study Arms (4)

first dose level

EXPERIMENTAL

ART105 OR Placebo

Drug: ART105; Drug: Placebo

second dose level

EXPERIMENTAL

ART105 OR Placebo

Drug: ART105; Drug: Placebo

third dose level

EXPERIMENTAL

ART105 OR Placebo

Drug: ART105; Drug: Placebo

fourth dose level

EXPERIMENTAL

ART105 OR Placebo

Drug: ART105; Drug: Placebo

Interventions

ART105 DRUG

injection

first dose level; fourth dose level; second dose level; third dose level

Placebo DRUG

injection

first dose level; fourth dose level; second dose level; third dose level

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any uncontrolled or severe disease, or any medical or surgical condition that may interfere with the participant's participation in the clinical trial
• History of hypersensitivity to oligonucleotide drugs, or known hypersensitivity to the investigational product or any of its excipients
• Use of any ASO or siRNA drugs within 12 months prior to the first dose
• History of alcohol abuse
• History of drug or substance abuse, or a positive urine drug abuse screening test
• Major surgery within 3 months prior to the administration of the investigational product or planned elective surgery during the study period.
• 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).
• 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
• 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).
• Occurrence of acute illness or use of concomitant medications from the screening phase until prior to the administration of the investigational product.
• Consumption of any alcohol-containing products or a positive breath alcohol test within 48 hours prior to the administration of the investigational product.
• Participants who, in the investigator's opinion, have other factors that make them unsuitable for participation in this study.

Sponsors & Collaborators

• Arnatar Therapeutics, Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 5, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share