HealthyPhase 1NCT05018403
First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects
A Phase 1 study testing Intravenous AON-D21 in people with Healthy, run by Aptarion Biotech AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intravenous AON-D21
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 3 Aug 2021to 5 Jan 2022
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-center, Double-blind, Placebo Controlled, First-in-human Trial With Single Ascending 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 single ascending intravenous doses of AON-D21 in healthy male subjects.
Read the 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
- Being tested
- Intravenous AON-D21, Intravenous placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous AON-D21Drug
Also called AON-D21
AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.
Intravenous placeboDrug
Also called Placebo
Isotonic glucose solution identical in appearance to AON-D21.
| Study group | Role | What they receive |
|---|---|---|
| AON-D21 | Experimental | Single ascending doses by iv infusion. Receives: Drug: Intravenous AON-D21 |
| Placebo | Placebo comparator | Placebo medication identical in appearance to active. Receives: Drug: Intravenous placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Overall number of participants with treatment-emergent adverse events (TEAEs) per dosing cohort as assessed by CTCAE.
To determine the overall safety and tolerability of AON-D21 by analyzing number of participants with treatment-related adverse events as assessed by CTCAE. Nature, occurrence, and severity of treatment-emergent adverse events.
Measured: 14 days.
Primary Safety Endpoint - Per Dosing Cohort number of participants with treatment-emergent adverse events as assessed by CTCAE.
Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE per dosing cohort.
Measured: 14 days
Secondary outcomes (10)
Pharmacokinetics of AON-D21.
To determine the area under the concentration (AUC)-time curve from 0 to 48 h (AUC0-48).
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the area under the concentration (AUC)-time curve from 0 to 72 h (AUC0-72).
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the area under the concentration (AUC)-time curve from 0 to infinity (AUC0-inf).
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the maximum concentration (Cmax).
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the time of maximum concentration (Tmax).
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the half-life (t1/2).
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the plasma clearance (CL) calculated as Dose/AUC0-inf.
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the volume of distribution (Vz).
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the amount of AON-D21 excreted (Ae) in urine.
Measured: 14 days.
Pharmacokinetics of AON-D21.
To determine the renal clearance (CLR) of AON-D21.
Measured: 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start3 Aug 2021
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Five groups of participants will be assigned to receive AON-D21 or placebo in ascending dose order. Doses will be escalated based on safety and pharmacokinetic data.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptarion Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuela Koch, MD, Principal investigator, Nuvisan GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018403
- Sponsor's protocol ID
- S-D21-C100
- Other IDs
- 2021-000935-30
- Status last verified
- Jan 2022
- First submitted
- 10 Aug 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Double-blind, Placebo Controlled, First-in-human Trial With Single Ascending Intravenous Doses to Determine Safety, Tolerability and Pharmacokinetics of AON-D21 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05018403
- Acronym / sponsor ID
- S-D21-C100
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aptarion Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 24 Aug 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Five groups of participants will be assigned to receive AON-D21 or placebo in ascending dose order. Doses will be escalated based on safety and pharmacokinetic data.
| Arm | Type | Receives |
|---|---|---|
| AON-D21 | Experimental | Drug: Intravenous AON-D21Single ascending doses by iv infusion. |
| Placebo | Placebo comparator | Drug: Intravenous placeboPlacebo medication identical in appearance to active. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Intravenous AON-D21Also: AON-D21AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors. | Drug | AON-D21 |
| Intravenous placeboAlso: PlaceboIsotonic glucose solution identical in appearance to AON-D21. | Drug | Placebo |
Primary outcome
Primary Safety Endpoint - Overall number of participants with treatment-emergent adverse events (TEAEs) per dosing cohort as assessed by CTCAE.
Time frame: 14 days.
To determine the overall safety and tolerability of AON-D21 by analyzing number of participants with treatment-related adverse events as assessed by CTCAE. Nature, occurrence, and severity of treatment-emergent adverse events.
Primary Safety Endpoint - Per Dosing Cohort number of participants with treatment-emergent adverse events as assessed by CTCAE.
Time frame: 14 days
Overall number of participants with treatment related treatment-emergent adverse events (TEAEs) as assessed by CTCAE per dosing cohort.
10 secondary outcomes
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
Pharmacokinetics of AON-D21.
Time frame: 14 days.
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 12 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Manuela Koch, MD principal investigator
Nuvisan GmbH
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 Intravenous AON-D21 in people with Healthy, run by Aptarion Biotech AG at 1 site in Germany.
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 6 inclusion and 16 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 12 Jan 2022. 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 Germany. 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?
Primary Safety Endpoint - Overall number of participants with treatment-emergent adverse events (TEAEs) per dosing cohort as assessed by CTCAE. (time frame: 14 days.). The study lists 2 primary outcomes in all. 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 12 Jan 2022.