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NCT Number: NCT07713485

Study of XmAb412 in Healthy Participants

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xencor Investigative Site, Joondalup, Western Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XmAb412 Monoclonal Bispecific Antibody

Drug

Monoclonal Bispecific Antibody

Placebo

Drug

Placebo

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

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

    Time frame: Up to 28 weeks

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

    Time frame: Up to 28 weeks

  7. • t1/2 (terminal elimination half-life

    Time frame: Up to 28 weeks

  8. • CL/F (apparent) total body clearance

    Time frame: Up to 28 weeks

  9. • Vz/F (apparent volume of distribution

    Time frame: Up to 28 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

412 Study Information

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xencor, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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