Healthy Participants StudyPhase 1NCT07236411
Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants
A Phase 1 study testing cizutamig in people with Healthy Participants Study, run by Candid Therapeutics at 1 site in Australia.
Trial summary
The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- cizutamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Dec 2025to 14 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Body mass index 18-30 kg/m2 and weight 55-100 kg
- Individuals in good health
- Meets vaccination requirements as defined by the protocol
- Agree to abstain from consumption of alcohol within 48-hrs of study visits
- Agree to the use of highly effective contraception as defined by the protocol
Who cannot join
- Active Infection
- Inadequate clinical laboratory parameters at Screening
- Receipt of or inability to discontinue any excluded therapies
- Individuals who will decline blood products
- Individuals with immediate household contacts with young children (eg, ≤ 6 years old) or immunocompromised persons
- History of drug or alcohol abuse within last 12 months
Show all 13Show fewer
- Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)
- History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug
- 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)
- Blood donation or significant blood loss within 30 days prior to screening
- Individuals considered to be part of a vulnerable population (eg, incarceration)
- Individuals that in the opinion of the Investigator, are not suitable for participation in the trial
- Inability to comply with protocol-mandated requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Phase 1 Study to Evaluate the Absolute Bioavailability of Cizutamig Following Single Intravenous or Subcutaneous Administration in Healthy Adult Participants
The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants.
Read the 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.
- Conditions
- Healthy Participants Study
- Being tested
- cizutamig, Placebo
- Keywords
- healthy volunteer, pharmacokinetics, pharmacodynamics, immune system, cizutamig, T cell engager, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cizutamigBiological
cizutamig will be dosed SC or IV according to the assigned cohort
PlaceboOther
placebo will be dosed IV or SC according to the assigned cohort
| Study group | Role | What they receive |
|---|---|---|
| SC injection of cizutamig | Experimental | cizutamig subcutaneous injection Receives: Biological: cizutamig |
| SC injection of placebo | Placebo comparator | placebo subcutaneous injection Receives: Other: Placebo |
| IV infusion of cizutamig | Experimental | IV cizutamig Receives: Biological: cizutamig |
| IV infusion of placebo | Placebo comparator | IV placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability
Measured: Baseline to 8 weeks
Secondary outcomes (28)
Incidence and severity of treatment-emergent adverse events through end of study
Measured: Baseline to 8 weeks
PK parameters for cizutamig: AUC and dose-normalized AUC
Measured: Baseline to 8 weeks
PK parameters for cizutamig: Cmax and dose-normalized Cmax
Measured: Baseline to 8 Weeks
PK parameter for cizutamig: Tmax
Measured: Baseline to 8 Weeks
PK parameter for cizutamig: t½
Measured: Baseline to 8 weeks
PK Parameters for cizutamig: CL
IV only
Measured: Baseline to 8 Weeks
PK Parameters for cizutamig: CL/F
SC only
Measured: Baseline to 8 weeks
Anti-drug antibodies (ADAs)
Measured: Baseline to 8 weeks
Changes in body temperature
oral, tympanic, or axillary
Measured: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QRS interval
Measured: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: PR interval
Measured: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QTcB
Measured: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QTcF
Measured: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QT interval
Measured: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: RR
Measured: Baseline to 8 Weeks
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Measured: Baseline to 8 Weeks
PK Parameters for cizutamig: Vz
IV only
Measured: Baseline to 8 weeks
PK Parameters for cizutamig: Vss
IV only
Measured: Baseline to 8 weeks
PK Parameters for cizutamig: Vz/F
SC only
Measured: Baseline to 8 Weeks
Changes in heart rate
Measured: Baseline to 8 weeks
Changes in respiratory rate
Measured: Baseline to 8 weeks
Changes in blood pressure
systolic and diastolic
Measured: Baseline to 8 weeks
Changes in pulse oximetry
Measured: Baseline to 8 weeks
Changes from baseline in Red Blood Cell count
Measured: Baseline to 8 weeks
Changes from baseline in White Blood Cell count
Measured: Baseline to 8 weeks
Changes from baseline in Platelets
Measured: Baseline to 8 weeks
Changes from baseline in Hematocrit
Measured: Baseline to 8 weeks
Changes from baseline in Hemoglobin
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start4 Dec 2025
- Primary completion16 Apr 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236411
- Sponsor's protocol ID
- CND106-001
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase 1 Study to Evaluate the Absolute Bioavailability of Cizutamig Following Single Intravenous or Subcutaneous Administration in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07236411
- Acronym / sponsor ID
- CND106-001
- Conditions
- Healthy Participants Study
- Keywords
- healthy volunteer, pharmacokinetics, pharmacodynamics, immune system, cizutamig, T cell engager, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Candid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 19 Nov 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SC injection of cizutamig | Experimental | Biological: cizutamigcizutamig subcutaneous injection |
| SC injection of placebo | Placebo comparator | Other: Placeboplacebo subcutaneous injection |
| IV infusion of cizutamig | Experimental | Biological: cizutamigIV cizutamig |
| IV infusion of placebo | Placebo comparator | Other: PlaceboIV placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years of age
- Body mass index 18-30 kg/m2 and weight 55-100 kg
- Individuals in good health
- Meets vaccination requirements as defined by the protocol
- Agree to abstain from consumption of alcohol within 48-hrs of study visits
Key exclusion criteria (13 listed)
- Active Infection
- Inadequate clinical laboratory parameters at Screening
- Receipt of or inability to discontinue any excluded therapies
- Individuals who will decline blood products
- Individuals with immediate household contacts with young children (eg, ≤ 6 years old) or immunocompromised persons
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 |
|---|---|---|
| cizutamigcizutamig will be dosed SC or IV according to the assigned cohort | Biological | IV infusion of cizutamig, SC injection of cizutamig |
| Placeboplacebo will be dosed IV or SC according to the assigned cohort | Other | IV infusion of placebo, SC injection of placebo |
Primary outcome
Absolute bioavailability
Time frame: Baseline to 8 weeks
28 secondary outcomes
Incidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to 8 weeks
PK parameters for cizutamig: AUC and dose-normalized AUC
Time frame: Baseline to 8 weeks
PK parameters for cizutamig: Cmax and dose-normalized Cmax
Time frame: Baseline to 8 Weeks
PK parameter for cizutamig: Tmax
Time frame: Baseline to 8 Weeks
PK parameter for cizutamig: t½
Time frame: Baseline to 8 weeks
PK Parameters for cizutamig: CL
Time frame: Baseline to 8 Weeks
PK Parameters for cizutamig: CL/F
Time frame: Baseline to 8 weeks
Anti-drug antibodies (ADAs)
Time frame: Baseline to 8 weeks
Changes in body temperature
Time frame: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QRS interval
Time frame: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: PR interval
Time frame: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QTcB
Time frame: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QTcF
Time frame: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: QT interval
Time frame: Baseline to 8 Weeks
Changes in ECG parameters from baseline through end of study: RR
Time frame: Baseline to 8 Weeks
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time frame: Baseline to 8 Weeks
PK Parameters for cizutamig: Vz
Time frame: Baseline to 8 weeks
PK Parameters for cizutamig: Vss
Time frame: Baseline to 8 weeks
PK Parameters for cizutamig: Vz/F
Time frame: Baseline to 8 Weeks
Changes in heart rate
Time frame: Baseline to 8 weeks
Changes in respiratory rate
Time frame: Baseline to 8 weeks
Changes in blood pressure
Time frame: Baseline to 8 weeks
Changes in pulse oximetry
Time frame: Baseline to 8 weeks
Changes from baseline in Red Blood Cell count
Time frame: Baseline to 8 weeks
Changes from baseline in White Blood Cell count
Time frame: Baseline to 8 weeks
Changes from baseline in Platelets
Time frame: Baseline to 8 weeks
Changes from baseline in Hematocrit
Time frame: Baseline to 8 weeks
Changes from baseline in Hemoglobin
Time frame: Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cizutamig in people with Healthy Participants Study, run by Candid Therapeutics at 1 site 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute bioavailability (time frame: Baseline to 8 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 22 Jul 2026.