A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXencor, Inc.
About this trial
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Major surgery within 12 weeks prior to dosing or planned within the study
Recurrent infections or active clinically significant infection
Active or untreated latent tuberculosis
Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
Trial design
Design model
Single group
Treatments tested in this trial
XmAb657
Biological/VaccineBiological
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame
Through Week 52Secondary outcomes
1
Serum concentration of XmAb657
Time frame
Through Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov