Healthy
Conditions
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
Interventions
DRUGART105
injection
DRUGPlacebo
injection
Sponsors
Arnatar Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs | Baseline to Day 85 | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to Day 85 | Changes from baseline in urine PC1 and PC2 levels |
Outcome results
None listed