A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2022-01-14

Brief Summary

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This is a study to determine the safety and pharmacokinetics of CDX-0159 administered subcutaneously in healthy subjects.

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Detailed Description

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CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.

The study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 administered subcutaneously in healthy subjects.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CDX-0159

Subjects will receive a single dose of CDX-0159

Group Type EXPERIMENTAL

CDX-0159

Intervention Type DRUG

Single subcutaneous dose of one of four dosages of CDX-0159

Normal Saline

Subjects will receive a single dose of normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Single subcutaneous dose of normal saline

Interventions

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CDX-0159

Single subcutaneous dose of one of four dosages of CDX-0159

Intervention Type DRUG

Normal saline

Single subcutaneous dose of normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* An informed consent signed and dated by the subject.
* 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) ≥ 18.5 kg/m2 to ≤ 35 kg/m2
* No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives.
* Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker, vaper, or regular user of any nicotine or cannabinoid containing products
* Willing to follow all study rules

Exclusion Criteria

* Women who are pregnant or nursing
* History of anaphylaxis or systemic reactions to food or other triggers
* Autoimmune disorders requiring more than topical medication
* Vaccination with live vaccines within 4 months prior to screening visit (subjects must agree to avoid live vaccination during the study and 4 months after).
* 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