Healthy ParticipantsPhase 1NCT07107802
Phase 1 Single Ascending Dose Study With ATX101
A Phase 1 study testing ATX101 in people with Healthy Participants, run by Aurobac Therapeutics SAS at 1 site in Portugal.
Trial summary
The main objective of this study is to assess the safety and tolerability of intravenously administered ATX101 in healthy adults following single ascending doses of ATX101. The pharmacokinetic profile of ATX101 and its metabolites will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- ATX101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Jul 2025to 24 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free written informed consent prior to any procedure required by the study.
- Male or female participant ≥18 and ≤50 years-old, at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 29.9 kg/m2 and a minimum weight of 48 kg for women and 50 kg for men and maximum weight of 100 kg (inclusive).
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities at screening and admission.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg), and anti-Hepatitis C virus antibodies (anti-HCVAb).
- A female participant is either be of non-childbearing potential; or using an accepted contraceptive method.
Who cannot join
- Previous exposure to ATX101 or to ATX101 drug substance.
- Known hypersensitivity/allergic reaction to the study drug substance or any of the excipients.
- Known severe hypersensitivity reaction to any other drug.
- If woman, she is breast-feeding.
- Rest systolic blood pressure (SBP) <90 mmHg or >140 mmHg.
- Rest diastolic blood pressure (DBP) <50 mmHg/or >95 mmHg.
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- Resting heart rate outside the range of 50 to 90 bpm, in the ECG.
- Hematological and biochemistry parameters outside the normal range.
- Renal function outside normal range.
- Positive result in drugs-of-abuse or ethanol tests.
- If woman of childbearing potential (WOCBP), positive pregnancy test.
- Use of a depot injection or an implant of any drug within the previous 6 months.
- Average weekly alcohol consumption of >14 units for males and >7 units for females, within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines, within the previous 6 months.
- Participation in any interventional clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Any other condition that the Investigator considers to render the participant unsuitable for the study.
- Any recent disease or condition or treatment that, according to the Investigator, would put the participant at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Fever (≥38 ºC) in the previous week.
- Use of prescription or nonprescription medicinal products, vitamins, food supplements or herbal supplements (including St John's Wort) within 2 weeks prior to admission to the study, unless in the Investigator's opinion the medication does not interfere with the pharmacokinetics of study drug or compromise participant safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Ascending Dose Study, to Assess the Safety and Pharmacokinetics of Intravenous ATX101 in Healthy Participants
The main objective of this study is to assess the safety and tolerability of intravenously administered ATX101 in healthy adults following single ascending doses of ATX101. The pharmacokinetic profile of ATX101 and its metabolites will also be investigated.
Read the detailed description
This is a single-center, double-blinded, placebo-controlled, phase I, single ascending dose study in healthy participants. A maximum of three ATX101 dose levels are pre-planned to be investigated in three separate sequential cohorts. Each of these cohorts will consist of 8 healthy participants (6 participants randomized to ATX101 and 2 to placebo). The study will consist of:
- a screening period, within 7 to 21 days before investigational product administration (Day -21 to Day -7),
- a treatment period, including admission to confinement, 3-night confinement, and discharge from confinement.
- a follow-up period, which includes two ambulatory follow-up visits (Day 4 and Day 7).
Total duration of study participation for each participant will be approximately 4 weeks.
- Conditions
- Healthy Participants
- Being tested
- ATX101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX101Drug
Single intravenous dose
PlaceboDrug
Single intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| ATX101 - low dose | Experimental | Not described Receives: Drug: ATX101 |
| ATX101 - middle dose | Experimental | Not described Receives: Drug: ATX101 |
| ATX101 - high dose | Experimental | Not described Receives: Drug: ATX101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of subjects with treatment-emergent adverse events (TEAEs). Occurrence of clinically relevant abnormalities on physical examination, safety laboratory tests, electrocardiogram parameters, and vital signs.
Measured: Up to Day 7
Secondary outcomes (11)
Maximum observed concentration (Cmax) of ATX101 in plasma
Measured: Up to Day 4
Time of occurrence of the maximum observed concentration (tmax) of ATX101 in plasma
Measured: Up to Day 4
Area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) up to the end of infusion (AUC0-T)
Measured: Up to Day 4
Partial area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) up to 24 hours after the start of infusion (AUC0-24)
Measured: Up to 24 hours
Area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) up to the time of last measurable concentration (AUC0-t)
Measured: Up to Day 4
Area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) extrapolated to infinity (AUC0-∞)
Measured: Up to Day 4
Residual area or percentage of extrapolated part of area under the concentration-time curve of ATX101 in plasma from the start of infusion (t=0h) extrapolated to infinity (%AUCextrap)
Measured: Up to Day 4
Apparent terminal elimination rate constant (λz) of ATX101 in plasma
Measured: Up to Day 4
Apparent terminal elimination half-life (t½) of ATX101 in plasma
Measured: Up to Day 4
Apparent volume of distribution (VD) of ATX101 in plasma
Measured: Up to Day 4
Apparent total body clearance (CL) of ATX101 in plasma
Measured: Up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start19 Jul 2025
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Aurobac Therapeutics SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107802
- Sponsor's protocol ID
- ATX101-CLN-1001
- Other IDs
- 2025-521999-56-00, 2025
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a healthy volunteer study being conducted to define the safety and pharmacokinetic profile of the tested drug. This study is not exploring the activity of our drug in the target indication population. As such, we do not believe there is utility for sharing deidentified IPD from this trial with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Ascending Dose Study, to Assess the Safety and Pharmacokinetics of Intravenous ATX101 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07107802
- Acronym / sponsor ID
- ATX101-CLN-1001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aurobac Therapeutics SASIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 6 Aug 2025 (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 main objective of this study is to assess the safety and tolerability of intravenously administered ATX101 in healthy adults following single ascending doses of ATX101. The pharmacokinetic profile of ATX101 and its metabolites will also be investigated.
Detailed description
This is a single-center, double-blinded, placebo-controlled, phase I, single ascending dose study in healthy participants. A maximum of three ATX101 dose levels are pre-planned to be investigated in three separate sequential cohorts. Each of these cohorts will consist of 8 healthy participants (6 participants randomized to ATX101 and 2 to placebo). The study will consist of:
- a screening period, within 7 to 21 days before investigational product administration (Day -21 to Day -7),
- a treatment period, including admission to confinement, 3-night confinement, and discharge from confinement.
- a follow-up period, which includes two ambulatory follow-up visits (Day 4 and Day 7).
Total duration of study participation for each participant will be approximately 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ATX101 - low dose | Experimental | Drug: ATX101 |
| ATX101 - middle dose | Experimental | Drug: ATX101 |
| ATX101 - high dose | Experimental | Drug: ATX101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Free written informed consent prior to any procedure required by the study.
- Male or female participant ≥18 and ≤50 years-old, at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 29.9 kg/m2 and a minimum weight of 48 kg for women and 50 kg for men and maximum weight of 100 kg (inclusive).
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities at screening and admission.
Key exclusion criteria (21 listed)
- Previous exposure to ATX101 or to ATX101 drug substance.
- Known hypersensitivity/allergic reaction to the study drug substance or any of the excipients.
- Known severe hypersensitivity reaction to any other drug.
- If woman, she is breast-feeding.
- Rest systolic blood pressure (SBP) <90 mmHg or >140 mmHg.
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 |
|---|---|---|
| ATX101Single intravenous dose | Drug | ATX101 - high dose, ATX101 - low dose, ATX101 - middle dose |
| PlaceboSingle intravenous dose | Drug | Placebo |
Primary outcome
Number and proportion of subjects with treatment-emergent adverse events (TEAEs). Occurrence of clinically relevant abnormalities on physical examination, safety laboratory tests, electrocardiogram parameters, and vital signs.
Time frame: Up to Day 7
11 secondary outcomes
Maximum observed concentration (Cmax) of ATX101 in plasma
Time frame: Up to Day 4
Time of occurrence of the maximum observed concentration (tmax) of ATX101 in plasma
Time frame: Up to Day 4
Area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) up to the end of infusion (AUC0-T)
Time frame: Up to Day 4
Partial area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) up to 24 hours after the start of infusion (AUC0-24)
Time frame: Up to 24 hours
Area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) up to the time of last measurable concentration (AUC0-t)
Time frame: Up to Day 4
Area under the concentration-time curve (AUC) of ATX101 in plasma from the start of infusion (t=0h) extrapolated to infinity (AUC0-∞)
Time frame: Up to Day 4
Residual area or percentage of extrapolated part of area under the concentration-time curve of ATX101 in plasma from the start of infusion (t=0h) extrapolated to infinity (%AUCextrap)
Time frame: Up to Day 4
Apparent terminal elimination rate constant (λz) of ATX101 in plasma
Time frame: Up to Day 4
Apparent terminal elimination half-life (t½) of ATX101 in plasma
Time frame: Up to Day 4
Apparent volume of distribution (VD) of ATX101 in plasma
Time frame: Up to Day 4
Apparent total body clearance (CL) of ATX101 in plasma
Time frame: Up to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. This is a healthy volunteer study being conducted to define the safety and pharmacokinetic profile of the tested drug. This study is not exploring the activity of our drug in the target indication population. As such, we do not believe there is utility for sharing deidentified IPD from this trial with other researchers.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATX101 in people with Healthy Participants, run by Aurobac Therapeutics SAS at 1 site in Portugal.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number and proportion of subjects with treatment-emergent adverse events (TEAEs). Occurrence of clinically relevant abnormalities on physical examination, safety laboratory tests, electrocardiogram parameters, and vital signs. (time frame: Up to Day 7). 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 28 Nov 2025.