A Phase I Study of CDX-622

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-04-30

Brief Summary

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

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Detailed Description

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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 IV single ascending doses (Part 1), IV multiple ascending doses (Part 2), and subcutaneous (SC) single ascending doses (Part 3) of CDX-622 in healthy participants.

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CDX-622

Eligible participants will receive doses of CDX-622 by IV or SC

Group Type EXPERIMENTAL

CDX-622

Intervention Type DRUG

Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622

Normal Saline

Eligible participants will receive doses of Normal Saline by IV or SC

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Up to 4 infusions or 6 SC injections of normal saline

Interventions

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CDX-622

Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622

Intervention Type DRUG

Normal Saline

Up to 4 infusions or 6 SC injections of normal saline

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes