Not Applicable - Healthy Adult ParticipantsPhase 1NCT07713485
Study of XmAb412 in Healthy Participants
A Phase 1 study testing XmAb412 Monoclonal Bispecific Antibody in people with Not Applicable - Healthy Adult Participants, run by Xencor, Inc. at 2 sites in Australia.
Trial summary
This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Not Applicable - Healthy Adult Participants
- What is being tested?
- XmAb412 Monoclonal Bispecific Antibody
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesAustralia
- Study dates
- 13 Jul 2026to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
412 Study Information contact
Australia2 sites, 2 recruiting
- Recruiting
Xencor Investigative Site
Joondalup, Western Australia, 6027
- Recruiting
Xencor Investigative Site
Nedlands, Western Australia, 6009
About this study
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
This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants
Read the detailed description
This study consists of 2 parts, as follows:
In Part A, participants will receive a single dose of XmAb412 using subcutaneous (SC) or intravenous (IV) administration route.
In Part B, participants will receive multiple doses of XmAb412 or placebo using SC or IV administration route.
- Being tested
- XmAb412 Monoclonal Bispecific Antibody, Placebo
- Keywords
- Inflammatory Bowel Disease, Health Adult Participants
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb412 Monoclonal Bispecific AntibodyDrug
Monoclonal Bispecific Antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: Active Drug | Active comparator | Active XmAb412 to be administered to healthy adult participants. Receives: Drug: XmAb412 Monoclonal Bispecific Antibody |
| Part A: Placebo | Placebo comparator | Placebo Comparator to be administered to healthy participants. Receives: Drug: Placebo |
| Part B: Active | Active comparator | Active XmAb412 to be administered to healthy participants. Receives: Drug: XmAb412 Monoclonal Bispecific Antibody |
| Part B: Placebo | Placebo comparator | Placebo Comparator to be administered to healthy participants. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 28 weeks
Secondary outcomes (9)
Serum PK parameters of XmAb412 in healthy adult participants (Part A and Part B)
Measured: Up to 28 weeks
Cmax (Maximum concentration of drug)
Measured: Up to 28 weeks
Tmax (Time of maximum concentration of drug)
Measured: Up to 28 weeks
• AUC0-last (Area under the curve drug concentration-time curve to last concentration)
Measured: Up to 28 weeks
• Repeat dose cohorts: AUC0-tau (AUC within a dosing interval
Measured: Up to 28 weeks
• AUC0-inf (AUC from time 0 extrapolated to infinity
Measured: Up to 28 weeks
• t1/2 (terminal elimination half-life
Measured: Up to 28 weeks
• CL/F (apparent) total body clearance
Measured: Up to 28 weeks
• Vz/F (apparent volume of distribution
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start13 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Not Applicable - Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 412 Study Information, Study director, Xencor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713485
- Sponsor's protocol ID
- XmAb412-01
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- XmAb412-01
- Keywords
- Inflammatory Bowel Disease, Health Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants
Detailed description
This study consists of 2 parts, as follows:
In Part A, participants will receive a single dose of XmAb412 using subcutaneous (SC) or intravenous (IV) administration route.
In Part B, participants will receive multiple doses of XmAb412 or placebo using SC or IV administration route.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Active Drug | Active comparator | Drug: XmAb412 Monoclonal Bispecific AntibodyActive XmAb412 to be administered to healthy adult participants. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator to be administered to healthy participants. |
| Part B: Active | Active comparator | Drug: XmAb412 Monoclonal Bispecific AntibodyActive XmAb412 to be administered to healthy participants. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator to be administered to healthy participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XmAb412 Monoclonal Bispecific AntibodyMonoclonal Bispecific Antibody | Drug | Part A: Active Drug, Part B: Active |
| PlaceboPlacebo | Drug | Part A: Placebo, Part B: Placebo |
Primary outcome
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)
Time frame: Up to 28 weeks
9 secondary outcomes
Serum PK parameters of XmAb412 in healthy adult participants (Part A and Part B)
Time frame: Up to 28 weeks
Cmax (Maximum concentration of drug)
Time frame: Up to 28 weeks
Tmax (Time of maximum concentration of drug)
Time frame: Up to 28 weeks
• AUC0-last (Area under the curve drug concentration-time curve to last concentration)
Time frame: Up to 28 weeks
• Repeat dose cohorts: AUC0-tau (AUC within a dosing interval
Time frame: Up to 28 weeks
• AUC0-inf (AUC from time 0 extrapolated to infinity
Time frame: Up to 28 weeks
• t1/2 (terminal elimination half-life
Time frame: Up to 28 weeks
• CL/F (apparent) total body clearance
Time frame: Up to 28 weeks
• Vz/F (apparent volume of distribution
Time frame: Up to 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
412 Study Information contact
412 Study Information study director
Xencor, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb412 Monoclonal Bispecific Antibody in people with Not Applicable - Healthy Adult Participants, run by Xencor, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 412 Study Information (XmAb412-01info@xencor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.