Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants

Candid Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants Study

Treatments: Biological: cizutamig; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07236411

CND106-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 4 patient groups, including a placebo group

SC injection of cizutamig

Experimental group

Description:

cizutamig subcutaneous injection

Treatment:

Biological: cizutamig

SC injection of placebo

Placebo Comparator group

Description:

placebo subcutaneous injection

Treatment:

Other: Placebo

IV infusion of cizutamig

Experimental group

Description:

IV cizutamig

Treatment:

Biological: cizutamig

IV infusion of placebo

Placebo Comparator group

Description:

IV placebo

Treatment:

Other: Placebo