Health TrialsbyHealthPanel

Study of XmAb412 in Healthy Participants

ConditionNot Applicable - Healthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorXencor, Inc.

About this trial

This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-55 years old

Must be in good health with no significant medical history

BMI 18-35 kg/m2

Contraceptive use consistent with local regulations

Disqualifiers

Any physical condition that prohibits study completion

Known hypersensitivity to the trial intervention or any of its components

HIV, hepatitis B and hepatitis C positive

Clinically significant abnormal ECG

Trial design

Design model

Sequential

Treatments tested in this trial

  • XmAb412 Monoclonal Bispecific Antibody

    Drug

    Monoclonal Bispecific Antibody

  • Placebo

    Drug

    Placebo

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: Part A: Active DrugActive comparator 1 intervention
Group B: Part A: PlaceboPlacebo comparator 1 intervention
Group C: Part B: ActiveActive comparator 1 intervention
Group D: Part B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb412 in healthy adult participants (Part A and Part B)

Time frame
Up to 28 weeks

Secondary outcomes

1

Serum PK parameters of XmAb412 in healthy adult participants (Part A and Part B)

Time frame
Up to 28 weeks
2

Cmax (Maximum concentration of drug)

Time frame
Up to 28 weeks
3

Tmax (Time of maximum concentration of drug)

Time frame
Up to 28 weeks
4

• AUC0-last (Area under the curve drug concentration-time curve to last concentration)

Time frame
Up to 28 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xencor, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now