Can a single injection of ART105 safely alter key body markers?
NCT ID NCT07748026
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This early-stage trial aims to see if a single injection of ART105 is safe and tolerable in healthy adults aged 18 to 55. It also looks at how the drug moves through the body and whether it changes urine PC1 levels. Participants receive one dose and are followed for about three months. The focus is on safety and basic drug behavior, not on treating any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ART105 (an experimental drug given as a single subcutaneous injection)
- What this could lead to
- If ART105 is safe and shows expected effects, it could pave the way for future studies in people with certain health conditions.
- What could go wrong
- This is an early, small trial in healthy volunteers, so results may not apply to patients. The drug may cause side effects or fail to show the desired effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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