Study of XmAb412 in Healthy Participants
Phase 1 · Testing XmAb412 Monoclonal Bispecific Antibody · 2 sites · Xencor, Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing XmAb412 Monoclonal Bispecific Antibody (a drug) as a possible treatment. Condition(s) listed: Not Applicable - Healthy Adult Participants.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 55
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Age 18-55 years old
- Must be in good health with no significant medical history
- BMI 18-35 kg/m2
Plus 2 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 128 participants are expected to take part.
- Start date: 2026-07-13.
- Main results expected around 2027-05 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Australia.
Main thing being measured
- 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)
In the researchers’ words
This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Not Applicable - Healthy Adult Participants |
| Lead sponsor | Xencor, Inc. |
| Enrollment | 128 (estimated) |
| Start date | 2026-07-13 |
| Primary completion (est.) | 2027-05 |
| First posted | 2026-07-20 |
| Last updated | 2026-08-03 |
| 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 |
| ClinicalTrials.gov ID | NCT07713485 |
Interventions
- XmAb412 Monoclonal Bispecific Antibody (Drug)
Monoclonal Bispecific Antibody - Placebo (Drug)
Placebo
Full eligibility criteria (from the record)
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)
| Site | City | Country | Site status |
|---|---|---|---|
| Xencor Investigative Site | Joondalup, Western Australia | Australia | Recruiting |
| Xencor Investigative Site | Nedlands, Western Australia | Australia | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.