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Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants

NCT ID: NCT07236411

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-04

Study Completion Date

2026-03-31

Brief Summary

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

Detailed Description

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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

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Healthy Participants Study

Keywords

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healthy volunteer pharmacokinetics pharmacodynamics immune system cizutamig T cell engager bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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SC injection of cizutamig

cizutamig subcutaneous injection

Group Type EXPERIMENTAL

cizutamig

Intervention Type BIOLOGICAL

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

SC injection of placebo

placebo subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

IV infusion of cizutamig

IV cizutamig

Group Type EXPERIMENTAL

cizutamig

Intervention Type BIOLOGICAL

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

IV infusion of placebo

IV placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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cizutamig

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Candid Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nucleus Network

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Clinical Operations

Role: CONTACT

Phone: +1 858-247-0550

Email: [email protected]

Other Identifiers

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CND106-001

Identifier Type: -

Identifier Source: org_study_id