First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects

NCT ID: NCT05018403

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2022-01-05

Brief Summary

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

Detailed Description

This study will potentially include 5 sequential cohorts with 8 subjects per cohort, then 40 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AON-D21

Single ascending doses by iv infusion.

Group Type: EXPERIMENTAL

Intravenous AON-D21

Intervention Type: DRUG

AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.

Placebo

Placebo medication identical in appearance to active.

Group Type: PLACEBO_COMPARATOR

Intravenous placebo

Intervention Type: DRUG

Isotonic glucose solution identical in appearance to AON-D21.

Interventions

Intravenous AON-D21

AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.

Intervention Type: DRUG

Intravenous placebo

Isotonic glucose solution identical in appearance to AON-D21.

Intervention Type: DRUG

Other Intervention Names

AON-D21; Placebo

Eligibility Criteria

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).
• 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 pharmacokinetic (PK) blood sample time point.
• Legal incapacity or limited legal capacity, or incarceration.
• Inability to understand or communicate reliably with the Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aptarion Biotech AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuela Koch, MD

Role: PRINCIPAL_INVESTIGATOR

Nuvisan GmbH

Locations

Nuvisan GmbH

Neu-Ulm, , Germany

Countries

Germany

Other Identifiers

2021-000935-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S-D21-C100

Identifier Type: -

Identifier Source: org_study_id