First human trial of a new antibody drug begins
NCT ID NCT07713485
First seen Jul 20, 2026 · Last updated Aug 04, 2026 · Updated 3 times
Summary
This study tests the safety and tolerability of a new drug called XmAb412, a monoclonal bispecific antibody, in healthy adults aged 18 to 55. Participants receive either the drug or a placebo, and researchers monitor for side effects and how the drug moves through the body. The goal is to gather early safety data before testing the drug in people with specific diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- XmAb412, a monoclonal bispecific antibody
- What this could lead to
- If safe and well-tolerated, this could pave the way for future studies of XmAb412 in specific diseases.
- What could go wrong
- This is an early, small Phase 1 trial focused on safety, not efficacy. The drug may not work or could have unexpected side effects.
Why investors are watching
Xencor is testing XmAb412, an experimental drug, in its first human trial with 128 healthy volunteers. This early-stage study checks whether the drug is safe and how the body processes it, and the results will give investors their first real signal on whether the drug has a future. For a small company like Xencor, this readout matters because a single drug's early data can shape its entire pipeline value.
If it works: If the trial shows XmAb412 is safe and well-tolerated, Xencor can move the drug into later-stage studies, which may expand its pipeline and attract partnership interest. A positive result would validate the company's research approach and support its broader drug development program.
If it fails: Phase 1 trials often fail because the drug proves unsafe or poorly tolerated, and any safety signal or delay could set the program back. For a small-cap company, a negative readout could reduce confidence in XmAb412 and weigh on the stock, though the company has other assets not described here.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xencor Investigative Site
RECRUITINGJoondalup, Western Australia, 6027, Australia
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Xencor Investigative Site
RECRUITINGNedlands, Western Australia, 6009, Australia