Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants

NCT07236411 | Active Not Recruiting Phase 1

• 1 other identifier: CND106-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants.

Conditions

Healthy Participants Study

Keywords

healthy volunteer; pharmacokinetics; pharmacodynamics; immune system; cizutamig; T cell engager; bioavailability

Outcome Measures

Primary Outcomes (1)

• Absolute bioavailability

  Baseline to 8 weeks

Secondary Outcomes (28)

• 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

Study Arms (4)

SC injection of cizutamig

EXPERIMENTAL

cizutamig subcutaneous injection

Biological: cizutamig

SC injection of placebo

PLACEBO COMPARATOR

placebo subcutaneous injection

Other: Placebo

IV infusion of cizutamig

EXPERIMENTAL

IV cizutamig

Biological: cizutamig

IV infusion of placebo

PLACEBO COMPARATOR

IV placebo

Other: Placebo

Interventions

cizutamig BIOLOGICAL

cizutamig will be dosed SC or IV according to the assigned cohort

IV infusion of cizutamig; SC injection of cizutamig

Placebo OTHER

placebo will be dosed IV or SC according to the assigned cohort

IV infusion of placebo; SC injection of placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Candid Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)