Healthy Participants Study
Conditions
Keywords
healthy volunteer, pharmacokinetics, pharmacodynamics, immune system, cizutamig, T cell engager, bioavailability
Brief summary
The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants.
Detailed description
This is a randomized, double-blind, Phase 1 study designed to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants. The study will enroll participants in SC and IV cohorts.
Interventions
BIOLOGICALcizutamig
cizutamig will be dosed SC or IV according to the assigned cohort
OTHERPlacebo
placebo will be dosed IV or SC according to the assigned cohort
Sponsors
Candid Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-65 years of age 2. Body mass index 18-30 kg/m2 and weight 55-100 kg 3. Individuals in good health 4. Meets vaccination requirements as defined by the protocol 5. Agree to abstain from consumption of alcohol within 48-hrs of study visits 6. Agree to the use of highly effective contraception as defined by the protocol
Exclusion criteria
1. Active Infection 2. Inadequate clinical laboratory parameters at Screening 3. Receipt of or inability to discontinue any excluded therapies 4. Individuals who will decline blood products 5. Individuals with immediate household contacts with young children (eg, ≤ 6 years old) or immunocompromised persons 6. History of drug or alcohol abuse within last 12 months 7. Individuals who are hypersensitive to intravenous immunoglobulin (IVIg) 8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug 9. Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period (from Screening to the individual's last visit) 10. Blood donation or significant blood loss within 30 days prior to screening 11. Individuals considered to be part of a vulnerable population (eg, incarceration) 12. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial 13. Inability to comply with protocol-mandated requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute bioavailability | Baseline to 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events through end of study | Baseline to 8 weeks | — |
| PK parameters for cizutamig: AUC and dose-normalized AUC | Baseline to 8 weeks | — |
| PK parameters for cizutamig: Cmax and dose-normalized Cmax | Baseline to 8 Weeks | — |
| PK parameter for cizutamig: Tmax | Baseline to 8 Weeks | — |
| PK parameter for cizutamig: t½ | Baseline to 8 weeks | — |
| PK Parameters for cizutamig: CL | Baseline to 8 Weeks | IV only |
| PK Parameters for cizutamig: CL/F | Baseline to 8 weeks | SC only |
| Anti-drug antibodies (ADAs) | Baseline to 8 weeks | — |
| Changes in body temperature | Baseline to 8 Weeks | oral, tympanic, or axillary |
| Changes in ECG parameters from baseline through end of study: QRS interval | Baseline to 8 Weeks | — |
| Changes in ECG parameters from baseline through end of study: PR interval | Baseline to 8 Weeks | — |
| Changes in ECG parameters from baseline through end of study: QTcB | Baseline to 8 Weeks | — |
| Changes in ECG parameters from baseline through end of study: QTcF | Baseline to 8 Weeks | — |
| Changes in ECG parameters from baseline through end of study: QT interval | Baseline to 8 Weeks | — |
| Changes in ECG parameters from baseline through end of study: RR | Baseline to 8 Weeks | — |
| Changes from baseline in safety laboratory assessments through end of study: serum chemistry | Baseline to 8 Weeks | — |
| PK Parameters for cizutamig: Vz | Baseline to 8 weeks | IV only |
| PK Parameters for cizutamig: Vss | Baseline to 8 weeks | IV only |
| PK Parameters for cizutamig: Vz/F | Baseline to 8 Weeks | SC only |
| Changes in heart rate | Baseline to 8 weeks | — |
| Changes in respiratory rate | Baseline to 8 weeks | — |
| Changes in blood pressure | Baseline to 8 weeks | systolic and diastolic |
| Changes in pulse oximetry | Baseline to 8 weeks | — |
| Changes from baseline in Red Blood Cell count | Baseline to 8 weeks | — |
| Changes from baseline in White Blood Cell count | Baseline to 8 weeks | — |
| Changes from baseline in Platelets | Baseline to 8 weeks | — |
| Changes from baseline in Hematocrit | Baseline to 8 weeks | — |
| Changes from baseline in Hemoglobin | Baseline to 8 weeks | — |
Countries
Australia
Outcome results
None listed