HealthyPhase 1NCT07748026
A Study of ART105 in Healthy Adult Participants
A Phase 1 study testing ART105 in people with Healthy, run by Arnatar Therapeutics, Inc..
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ART105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2026to 25 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
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
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
- Being tested
- ART105, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART105Drug
injection
PlaceboDrug
injection
| Study group | Role | What they receive |
|---|---|---|
| first dose level | Experimental | ART105 OR Placebo Receives: Drug: ART105; Drug: Placebo |
| second dose level | Experimental | ART105 OR Placebo Receives: Drug: ART105; Drug: Placebo |
| third dose level | Experimental | ART105 OR Placebo Receives: Drug: ART105; Drug: Placebo |
| fourth dose level | Experimental | ART105 OR Placebo Receives: Drug: ART105; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline to Day 85
Secondary outcomes (7)
Plasma maximum observed concentration (Cmax) of ART105
Measured: Baseline to Day 3
Plasma time to maximum observed concentration (Tmax) of ART105
Measured: Baseline to Day 3
Plasma half-life (t½) of ART105
Measured: Baseline to Day 3
Plasma area under the concentration-time curve up to 24 hr post dose (AUC0-24) of ART105
Measured: Baseline to Day 3
Fraction of ART105 excreted in the urine (fe)
Measured: Baseline to Day 3
Total amount of ART105 excreted in the urine (Ae)
Measured: Baseline to Day 3
PD biomarkers change
Changes from baseline in urine PC1 and PC2 levels
Measured: Baseline to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion25 Feb 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arnatar Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748026
- Sponsor's protocol ID
- ART105-CN-01
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07748026
- Acronym / sponsor ID
- ART105-CN-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Arnatar Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| first dose level | Experimental | Drug: ART105, Drug: PlaceboART105 OR Placebo |
| second dose level | Experimental | Drug: ART105, Drug: PlaceboART105 OR Placebo |
| third dose level | Experimental | Drug: ART105, Drug: PlaceboART105 OR Placebo |
| fourth dose level | Experimental | Drug: ART105, Drug: PlaceboART105 OR Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ART105injection | Drug | first dose level, fourth dose level, second dose level, third dose level |
| Placeboinjection | Drug | first dose level, fourth dose level, second dose level, third dose level |
Primary outcome
Incidence of AEs
Time frame: Baseline to Day 85
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ART105 in people with Healthy, run by Arnatar Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: Baseline to Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.