Healthy Clinical Trial
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
Verified date | January 2022 |
Source | Aptarion Biotech AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 5, 2022 |
Est. primary completion date | January 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Nuvisan GmbH | Neu-Ulm |
Lead Sponsor | Collaborator |
---|---|
Aptarion Biotech AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pharmacodynamics | To determine the C5a inhibition capacity of AON-D21 by measuring active C5a in blood using a cell-based assay. | 14 days | |
Other | Effects on the complement status | Determining the effect of AON-D21 on levels of C5, C5a, C5b-9 in blood and on the capacity of terminal complement complex formation. | 14 days | |
Other | To assess potential for immunogenicity of AON-D21 | Determining the presence of anti-drug antibodies (ADA) and anti-peg antibodies in serum. | 14 days | |
Primary | 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. | 14 days. | |
Primary | 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. | 14 days | |
Secondary | Pharmacokinetics of AON-D21. | To determine the area under the concentration (AUC)-time curve from 0 to 48 h (AUC0-48). | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the area under the concentration (AUC)-time curve from 0 to 72 h (AUC0-72). | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the area under the concentration (AUC)-time curve from 0 to infinity (AUC0-inf). | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the maximum concentration (Cmax). | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the time of maximum concentration (Tmax). | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the half-life (t1/2). | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the plasma clearance (CL) calculated as Dose/AUC0-inf. | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the volume of distribution (Vz). | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the amount of AON-D21 excreted (Ae) in urine. | 14 days. | |
Secondary | Pharmacokinetics of AON-D21. | To determine the renal clearance (CLR) of AON-D21. | 14 days. |
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