Study of XmAb412 in Healthy Participants

NCT07713485 | Recruiting Phase 1 DMC

• 1 other identifier: XmAb412-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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

Keywords

Inflammatory Bowel Disease; Health Adult Participants

Outcome Measures

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)

  Up to 28 weeks

Secondary Outcomes (9)

• 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

Study Arms (4)

Part A: Active Drug

ACTIVE COMPARATOR

Active XmAb412 to be administered to healthy adult participants.

Drug: XmAb412 Monoclonal Bispecific Antibody

Part A: Placebo

PLACEBO COMPARATOR

Placebo Comparator to be administered to healthy participants.

Drug: Placebo

Part B: Active

ACTIVE COMPARATOR

Active XmAb412 to be administered to healthy participants.

Drug: XmAb412 Monoclonal Bispecific Antibody

Part B: Placebo

PLACEBO COMPARATOR

Placebo Comparator to be administered to healthy participants.

Drug: Placebo

Interventions

XmAb412 Monoclonal Bispecific Antibody DRUG

Monoclonal Bispecific Antibody

Part A: Active Drug; Part B: Active

Placebo DRUG

Placebo

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (2)

Xencor Investigative Site

Joondalup, Western Australia, 6027, Australia

RECRUITING

Xencor Investigative Site

Nedlands, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• 412 Study Information, MD, MSCE

  Xencor, Inc.

  STUDY DIRECTOR

Central Study Contacts

412 Study Information

CONTACT

XmAb412-01info@xencor.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)