Study of XmAb412 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XmAb412 Monoclonal Bispecific Antibody, Placebo.
- Who it may be relevant to
- Registry conditions: Not Applicable - Healthy Adult Participants. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug XmAb412 Monoclonal Bispecific Antibody
Monoclonal Bispecific Antibody - Drug Placebo
Placebo
Primary outcome measures
- 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]
Secondary outcome measures (9)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 2 centers
- Xencor Investigative Site — Joondalup
- Xencor Investigative Site — Nedlands
Identifiers
NCT: NCT07713485 · XmAb412-01