Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants Study
• Intervention / Treatment: Biological: cizutamig; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SC injection of cizutamig; cizutamig subcutaneous injection	Biological: cizutamig; cizutamig will be dosed SC or IV according to the assigned cohort
Placebo Comparator: SC injection of placebo; placebo subcutaneous injection	Other: Placebo; placebo will be dosed IV or SC according to the assigned cohort
Experimental: IV infusion of cizutamig; IV cizutamig	Biological: cizutamig; cizutamig will be dosed SC or IV according to the assigned cohort
Placebo Comparator: IV infusion of placebo; IV placebo	Other: Placebo; placebo will be dosed IV or SC according to the assigned cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute bioavailability	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	IV only	Baseline to 8 Weeks
PK Parameters for cizutamig: CL/F	SC only	Baseline to 8 weeks
Anti-drug antibodies (ADAs)		Baseline to 8 weeks
Changes in body temperature	oral, tympanic, or axillary	Baseline to 8 Weeks
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	IV only	Baseline to 8 weeks
PK Parameters for cizutamig: Vss	IV only	Baseline to 8 weeks
PK Parameters for cizutamig: Vz/F	SC only	Baseline to 8 Weeks
Changes in heart rate		Baseline to 8 weeks
Changes in respiratory rate		Baseline to 8 weeks
Changes in pulse oximetry		Baseline to 8 weeks
Changes in blood pressure	systolic and diastolic	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

Collaborators and Investigators

• Sponsor: Candid Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: healthy volunteer; pharmacokinetics; bioavailability; immune system; pharmacodynamics; T cell engager; cizutamig
• Other Study ID Numbers: CND106-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No