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NCT07713485

Overview

NCT ID: NCT07713485
Lead Sponsor: Xencor, Inc.INDUSTRY
Official Title: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple-dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of XmAb412 in Healthy Adult Participants
Brief Summary: This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants
Conditions: Not Applicable - Healthy Adult Participants
Interventions: XmAb412 Monoclonal Bispecific Antibody
Placebo

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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

Able and willing to provide written informed consent

Exclusion Criteria:

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

Use of other investigational products within 5 half lives from Screening

Blood or plasma donation within 60 days from Screening

Pregnant or breastfeeding

Other protocol defined inclusion/exclusion criteria apply

Participant Group/Arms

Part A: Active DrugActive Comparator

Active XmAb412 to be administered to healthy adult participants.

Drug: XmAb412 Monoclonal Bispecific Antibody

Part A: PlaceboPlacebo Comparator

Placebo Comparator to be administered to healthy participants.

Drug: Placebo

Part B: ActiveActive Comparator

Active XmAb412 to be administered to healthy participants.

Drug: XmAb412 Monoclonal Bispecific Antibody

Part B: PlaceboPlacebo Comparator

Placebo Comparator to be administered to healthy participants.

Drug: Placebo