Ascending Multiple Intravenous Doses of AON-D21 in Healthy Male Subjects.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: AON-D21

• Registration Number: NCT05343819
• Lead Sponsor: Aptarion Biotech AG

Brief Summary

The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after multiple ascending intravenous doses of AON-D21 in healthy male subjects.

Detailed Description

This study will potentially include 2 two sequential cohorts with 8 healthy male subjects per cohort, then 16 enrolled subjects in total. Within each dose group 6 subjects will be randomized to receive AON-D21 and 2 subjects will be randomly assigned to placebo.

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• 18 to 55 years of age inclusive, at the time of signing the informed consent.
• Body mass index (BMI) within the range 18 - 30 kg/m2 with a body weight between 50 kg and 120 kg.
• Male subjects
• Subject is healthy as determined by medical evaluation
• Subject provided written informed consent
• Subject is willing to comply with all requirements and restrictions according to the study protocol.

Exclusion Criteria

• Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
• Any acquired or congenital immune deficiency.
• Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
• Clinically relevant abnormality following the Investigator's review of the physical examination, vital signs, ECG and clinical study protocol-defined clinical laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the trial at screening and admission.
• Evidence of COVID-19 signs or symptoms, exposure to infected person or confirmed COVID-19 infection within the last 2 weeks.
• Use of any concomitant medication or prescribed or non-prescribed drugs within 2 weeks or 5 times the half-life, whichever is longer, prior to the first study treatment administration.
• Administration of vaccine(s) within 2 weeks prior to screening or plans to receive such vaccines during the study.
• Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times, whichever is longer, prior to dosing.
• Positive drug or alcohol screen at screening and admission.
• Any significant blood loss, donated one unit (450 mL) of blood or more, or donated plasma, or received a transfusion of any blood or blood products within 30 days prior to dosing.
• Subjects who are unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice and /or pomelos, exotic citrus fruits, grapefruit hybrids, starfruit or fruit juices from 72 hours prior to dosing on Day 1, until completion of the last PK blood sample time point.
• Legal incapacity or limited legal capacity, or incarceration.
• Inability to understand or communicate reliably with the Investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo medication identical in appearance to active
AON-D21	AON-D21	Multiple ascending doses by iv infusion

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	27 days	Nature, occurrence, and severity of treatment-emergent adverse events.
Per dosing cohort number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.	27 days	Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 per dosing cohort.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics assessment	27 days	Terminal half life (t1/2) after the first dose of AON-D21 in plasma.
Pharmacodynamics assessment	27 days	Qualitative assessment of terminal complement complex (TCC) formation in plasma.
To assess potential for immunogenicity	27 days	Measurement of anti-polyethylene glycol (PEG) antibodies in plasma.

Trial Locations

Locations (1)

Nuvisan GmbH; 🇩🇪 Neu-Ulm, Germany