Phase 1 Single Ascending Dose Study With ATX101

NCT07107802 | Completed Phase 1

• 2 other identifiers: ATX101-CLN-10012025-521999-56-00
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Day 7

Secondary Outcomes (11)

• Maximum observed concentration (Cmax) of ATX101 in plasma

  Up to Day 4

• Time of occurrence of the maximum observed concentration (tmax) of ATX101 in plasma

  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)

  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)

  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)

  Up to Day 4

Other Outcomes (10)

• Maximum observed concentration (Cmax) of ATX101 metabolites in plasma

  Up to Day 4

• Time of occurrence of the maximum observed concentration (tmax) of ATX101 metabolites in plasma

  Up to Day 4

• Area under the concentration-time curve (AUC) of ATX101 metabolites in plasma from the start of infusion (t=0h) up to the end of infusion (AUC0-T)

  Up to Day 4

Study Arms (4)

ATX101 - low dose

EXPERIMENTAL

Drug: ATX101

ATX101 - middle dose

EXPERIMENTAL

Drug: ATX101

ATX101 - high dose

EXPERIMENTAL

Drug: ATX101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ATX101 DRUG

Single intravenous dose

ATX101 - high dose; ATX101 - low dose; ATX101 - middle dose

Placebo DRUG

Single intravenous dose

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aurobac Therapeutics SAS: lead

Study Sites (1)

BlueClinical Phase I

Porto, 4250-449, Portugal

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 6, 2025
• Study Start: July 19, 2025
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)