A Phase I Study of CDX-622

Celldex Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Normal Saline; Drug: CDX-622

Study type: Interventional

Funder types: Industry

Identifiers

NCT06650761

CDX622-01

Details and patient eligibility

About

This is a study to determine the safety of CDX-622 in healthy participants.

Full description

CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).

This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in healthy participants.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• An informed consent signed and dated by the participant.
• Healthy volunteer aged 18-55.
• In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
• Body mass index (BMI) ≥ 18 kg/m2 to ≤ 32 kg/m2.
• No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.
• Both males and females of childbearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
• Not a current smoker (or regular user of any nicotine containing product).
• Willing to follow all study rules.

Key Exclusion Criteria:

• Women who are pregnant or nursing.
• History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication.
• History of asthma requiring the use of inhaled medication within the past 5 years.
• Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
• Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
• Positive urine test for alcohol and drugs of abuse.

Additional protocol defined inclusion and exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

56 participants in 2 patient groups, including a placebo group

CDX-622

Experimental group

Description:

Eligible participants will receive up to three doses of CDX-622.

Treatment:

Drug: CDX-622

Normal Saline

Placebo Comparator group

Description:

Eligible participants will receive up to three doses of Normal Saline.

Treatment:

Drug: Normal Saline