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Not yet recruiting NCT07748026

A Study of ART105 in Healthy Adult Participants

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ART105, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug ART105
    injection
  • Drug Placebo
    injection

Primary outcome measures

  • Incidence of AEs [Time frame: Baseline to Day 85]
Secondary outcome measures (7)
  • Plasma maximum observed concentration (Cmax) of ART105 [Time frame: Baseline to Day 3]
  • Plasma time to maximum observed concentration (Tmax) of ART105 [Time frame: Baseline to Day 3]
  • Plasma half-life (t½) of ART105 [Time frame: Baseline to Day 3]
  • Plasma area under the concentration-time curve up to 24 hr post dose (AUC0-24) of ART105 [Time frame: Baseline to Day 3]
  • Fraction of ART105 excreted in the urine (fe) [Time frame: Baseline to Day 3]
  • Total amount of ART105 excreted in the urine (Ae) [Time frame: Baseline to Day 3]
  • PD biomarkers change [Time frame: Baseline to Day 85]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07748026 · ART105-CN-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗