XmAb412 in healthy adults
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
Run by Xencor, Inc. · NCT07713485 · Data updated 2026-11-12
This Phase 1 study tests XmAb412 in healthy adults to see how it behaves in the body and how safe it is.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Xencor, Inc. Industry-sponsored |
| Locations | 2 sites (Joondalup, Western Australia and 1 other locations) |
| Status | Recruiting |
| Started | July 13, 2026 |
| Main results expected | May 2027 |
| Study ends | March 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07713485 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18-55 without significant medical history who agree to comply with study procedures and contraception requirements.
✕Probably not a fit
Participants with significant medical conditions, infectious diseases, abnormal ECGs, pregnancy, or recent use of other investigational therapies are unlikely to benefit and may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-part Phase 1 trial evaluating XmAb412 in healthy adult participants. Part A tests a single dose by subcutaneous or intravenous administration, while Part B tests multiple doses versus placebo by either route. The study will measure safety, tolerability, pharmacokinetics and pharmacodynamics to understand the molecule's profile in healthy volunteers. Eligible participants are adults 18 to 55 in good health, without significant medical history, and willing to provide informed consent. Key exclusions include current illness, significant ECG abnormalities, infectious diseases, pregnancy, and recent use of other investigational products.
Why it matters
Potential benefit: If successful, participants may experience no direct benefit, but the study could advance understanding of XmAb412 for future patient populations.
How similar studies have gone: Previous early-stage studies of XmAb-family antibodies have shown safety and pharmacokinetic signals in healthy volunteers, but the specific XmAb412 approach is an initial evaluation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Xencor Investigative Site
Joondalup, Western Australia, Australia Recruiting -
Xencor Investigative Site
Nedlands, Western Australia, Australia Recruiting
Study contacts
- Study coordinator: 412 Study Information
- Email: XmAb412-01info@xencor.com
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.