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

December 16, 2022 updated by: Aptarion Biotech AG

A Randomized, Single-center, Double-blind, Placebo Controlled Trial With Ascending Multiple Intravenous Doses to Determine Safety, Tolerability and Pharmacokinetics of AON-D21 in Healthy Male Subjects.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Neu-Ulm, Germany, 89231
        • Nuvisan GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AON-D21
Multiple ascending doses by iv infusion
Drug: AON-D21
AON-D21 is a PEGylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.
Placebo Comparator: Placebo
Placebo medication identical in appearance to active
Drug: Placebo
Isotonic glucose solution identical in appearance to AON-D21.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 27 days
Nature, occurrence, and severity of treatment-emergent adverse events.
27 days
Per dosing cohort number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0.
Time Frame: 27 days
Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 per dosing cohort.
27 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics assessment
Time Frame: 27 days
Area under the concentration-time curve (AUC) over the dosing interval at steady state (AUC0-tau) of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Maximum concentration at steady state (Cmax) of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Average drug concentration at steady state (Cav) of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Trough concentrations (Ctrough) of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Time of maximum concentration at steady state (Tmax) of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Terminal half-life at steady state (t1/2) of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Accumulation ratios for Cmax and AUC of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Clearance (CL) of AON-D21 in plasma at steady state.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Volume of distribution (Vz) of AON-D21 in plasma at steady state.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
AUC from 0 to 48 hours (AUC0-48) after the first dose of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
AUC from 0 extrapolated to infinity (AUC0-inf) after the first dose of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Maximum concentration (Cmax) after the first dose of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Time to maximum concentration (Tmax) after the first dose of AON-D21 in plasma.
27 days
Pharmacokinetics assessment
Time Frame: 27 days
Terminal half life (t1/2) after the first dose of AON-D21 in plasma.
27 days
Pharmacodynamics assessment
Time Frame: 27 days
Measurement of concentration of C5 in plasma.
27 days
Pharmacodynamics assessment
Time Frame: 27 days
Measurement of concentration of C5a in plasma.
27 days
Pharmacodynamics assessment
Time Frame: 27 days
Measurement of concentration of C5b-9 in plasma.
27 days
Pharmacodynamics assessment
Time Frame: 27 days
Qualitative assessment of terminal complement complex (TCC) formation in plasma.
27 days
To assess potential for immunogenicity
Time Frame: 27 days
Measurement of anti-drug antibodies (ADA) in plasma.
27 days
To assess potential for immunogenicity
Time Frame: 27 days
Measurement of anti-polyethylene glycol (PEG) antibodies in plasma.
27 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aptarion Biotech AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-D21-C200
  • 2021-006551-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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