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

Aptarion Biotech

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Intravenous placebo

Drug: Intravenous AON-D21

Study type

Interventional

Funder types

Industry

Identifiers

NCT05018403

2021-000935-30 (EudraCT Number)

S-D21-C100

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.