A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
- Conditions
- Healthy Volunteers
- Registration Number
- NCT05670704
- Lead Sponsor
- argenx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria:<br><br> - Has reached the age of consent at the time of signing the informed consent form and<br> =65 years of age<br><br> - Is capable of providing signed informed consent and understands and is capable of<br> complying with protocol requirements<br><br> - Is a healthy participant, defined as having no clinically meaningful abnormalities<br> identified in any of the following assessments before the first IMP administration<br> on day 1: medical history, physical examination, standard 12-lead ECG, vital sign<br> measurements, and clinical laboratory tests<br><br> - Is either male or female of nonchildbearing potential.<br><br> - Has negative serum pregnancy tests at both screening and on day -1 (female<br> participants)<br><br> - Has a BMI within the range of 18 to 30 kg/m2 and a body weight within the range of<br> 50 to 100 kg (inclusive) before first IMP administration<br><br> - Agree to use contraceptive measures consistent with local regulations<br><br> - Agrees to discontinue and refrain from using all medications, including<br> nonprescription and prescription medications, for =2 weeks before their first IMP<br> administration through the study. The occasional use of paracetamol is allowed upon<br> approval by the investigator.<br><br> - Is a nonsmoker (defined as an individual who has abstained from smoking for =3<br> months before screening) and does not use nicotine-containing products<br><br> - Has a negative drug and alcohol test for amphetamines, barbiturates,<br> benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants,<br> and alcohol at screening and on day -1<br><br> - Has a body temperature of 35.5 °C to 37.6 °C at screening and before their first IMP<br> administration on day 1<br><br>Exclusion Criteria:<br><br> - Has a known hypersensitivity to any of the components of the IMP, or has a history<br> of a significant allergic reaction to any drug that is considered exclusionary by<br> the investigator<br><br> - Has been given an investigational product within 3 months or 5 half-lives (whichever<br> is longer) before their first IMP administration<br><br> - Has a positive serum test at screening for an active infection with any of the<br> following conditions: HBV that is indicative of an acute or chronic infection,<br> unless associated with a negative HBsAg or negative HBV DNA test, HCV based on HCV<br> antibody assay unless a negative RNA test is available, HIV based on test results<br><br> - Has a positive COVID-19 test result on day -1, if performed.<br><br> - Has a history of any medical or psychiatric condition that, in the opinion of the<br> investigator, is clinically meaningful, may confound the result of the study, or may<br> pose additional risks to the participant while taking part in the study<br><br> - Has clinically relevant abnormalities detected on an ECG that are related to either<br> rhythm or conduction<br><br> - Has a clinically meaningful abnormality in any screening test or vital sign<br> measurement before their first IMP administration<br><br> - Has had an event causing significant blood loss (including blood donation >500 mL)<br> or a transfusion of any blood product =12 weeks before their first IMP<br> administration<br><br> - Has a history of any of the following: Consuming >21 units of alcoholic beverages<br> per week =2 years before screening; Alcoholism or drug, chemical, or substance abuse<br> =2 years before screening; Consuming a large quantity (>6 cups a day) of coffee,<br> tea, or equivalent during the 4 week screening period<br><br> - Has any condition that impairs phlebotomy, including (but not limited to)<br> coagulation disorders (hemophilia A, hemophilia B, Von Willebrand disease), clotting<br> factor deficiencies, or any other condition that would increase the risk of hematoma<br> formation<br><br> - Is an investigator, subinvestigator, research assistant, pharmacist, study<br> coordinator, or other staff or relative of study personnel directly involved with<br> the conduct of the study<br><br> - Has any condition or circumstances that, in the opinion of the investigator, may<br> make a participant unlikely or unable to complete the study or comply with study<br> procedures and requirements
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of treatment-emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters of ARGX-119: Area Under The Curve (AUC);Pharmacokinetic parameters of ARGX-119: Maximum serum concentrations (Cmax);Pharmacokinetic parameters of ARGX-119: Time to reach maximum serum concentrations (Tmax);Incidence of antidrug antibodies against ARGX-119