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

NCT05031624 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CDX0159-05
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

CDX0159-05

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials

  Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials

  Day 1 to Day 85

Secondary Outcomes (4)

• CDX-0159 serum evaluations over time

  Day 1 to Day 85

• Serum tryptase levels over time

  Day 1 to Day 85

• Plasma levels over time

  Day 1 to Day 85

• Measurement of Anti-drug Antibody development over time

  Day 1 to Day 85

Study Arms (2)

CDX-0159

EXPERIMENTAL

Subjects will receive a single dose of CDX-0159

Drug: CDX-0159

Normal Saline

PLACEBO COMPARATOR

Subjects will receive a single dose of normal saline

Drug: Normal saline

Interventions

CDX-0159 DRUG

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

CDX-0159

Normal saline DRUG

Single subcutaneous dose of normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (1)

Celerion, Inc

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 2, 2021
• Study Start: August 30, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

US (1)