Study of XmAb412 in Healthy Participants

Phase 1RecruitingNCT07713485

Xencor, Inc.128 enrolled

Overview

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

This study consists of 2 parts, as follows: In Part A, participants will receive a single dose of XmAb412 using subcutaneous (SC) or intravenous (IV) administration route. In Part B, participants will receive multiple doses of XmAb412 or placebo using SC or IV administration route.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

128

Conditions

Not Applicable - Healthy Adult Participants

Interventions

XmAb412 Monoclonal Bispecific AntibodyDRUG

Monoclonal Bispecific Antibody

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Xencor Investigative Site

Joondalup, Western Australia, Australia

RECRUITING

Xencor Investigative Site

Nedlands, Western Australia, Australia

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: Up to 28 weeks

Cmax (Maximum concentration of drug)

Time frame: Up to 28 weeks

Tmax (Time of maximum concentration of drug)

Time frame: Up to 28 weeks

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

Time frame: Up to 28 weeks

• Repeat dose cohorts: AUC0-tau (AUC within a dosing interval

Time frame: Up to 28 weeks

• AUC0-inf (AUC from time 0 extrapolated to infinity

Time frame: Up to 28 weeks

• t1/2 (terminal elimination half-life

Time frame: Up to 28 weeks

• CL/F (apparent) total body clearance

Time frame: Up to 28 weeks

• Vz/F (apparent volume of distribution

Time frame: Up to 28 weeks

Central Contacts

412 Study Information

CONTACT

XmAb412-01info@xencor.com

Data from ClinicalTrials.gov

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