Study of XmAb412 in Healthy Participants

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07713485

Enrollment

128

Registered

2026-07-20

Start date

2026-07-13

Completion date

2028-03-01

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not Applicable - Healthy Adult Participants

Keywords

Inflammatory Bowel Disease, Health Adult Participants

Brief summary

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

Detailed description

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.

Interventions

DRUGXmAb412 Monoclonal Bispecific Antibody

Monoclonal Bispecific Antibody

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
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)	Up to 28 weeks

Secondary

Measure	Time frame
Serum PK parameters of XmAb412 in healthy adult participants (Part A and Part B)	Up to 28 weeks
Cmax (Maximum concentration of drug)	Up to 28 weeks
Tmax (Time of maximum concentration of drug)	Up to 28 weeks
• AUC0-last (Area under the curve drug concentration-time curve to last concentration)	Up to 28 weeks
• Repeat dose cohorts: AUC0-tau (AUC within a dosing interval	Up to 28 weeks
• AUC0-inf (AUC from time 0 extrapolated to infinity	Up to 28 weeks
• t1/2 (terminal elimination half-life	Up to 28 weeks
• CL/F (apparent) total body clearance	Up to 28 weeks
• Vz/F (apparent volume of distribution	Up to 28 weeks

Countries

Australia

Contacts

CONTACT412 Study Information

XmAb412-01info@xencor.com

STUDY_DIRECTOR412 Study Information

Xencor, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026