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First human trial of a new antibody drug begins

NCT ID NCT07713485

Knowledge-focused Sponsor: Xencor, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Not applicable - healthy adult participants

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. 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

  • Xencor Investigative Site

    RECRUITING

    Joondalup, Western Australia, 6027, Australia

  • Xencor Investigative Site

    RECRUITING

    Nedlands, Western Australia, 6009, Australia