A Phase 1 Study of CDX-0159
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 in Healthy Subjects
1 other identifier
interventional
32
1 country
1
Brief Summary
This is a study to determine the safety of CDX-0159 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedStudy Start
First participant enrolled
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2020
CompletedJuly 7, 2020
July 1, 2020
5 months
October 29, 2019
July 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety as assessed by CTCAE v5.0
Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.
Day 1 to Day 43.
Study Arms (2)
CDX-0159
EXPERIMENTALEligible subjects will receive a single dose of CDX-0159
Normal saline
PLACEBO COMPARATORSubjects assigned to receive placebo will receive a single dose of normal saline
Interventions
Eligibility Criteria
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 ≤ 30 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 (or regular user of any nicotine containing product).
- Willing to follow all study rules
You may not qualify if:
- Women who are pregnant or nursing
- History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication
- Autoimmune disorders requiring more than topical medication
- History of asthma requiring the use of inhaled medication within the past 5 years.
- Vaccination with live vaccines within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
- Positive urine test for alcohol and drugs of abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
October 31, 2019
Study Start
October 29, 2019
Primary Completion
April 6, 2020
Study Completion
June 26, 2020
Last Updated
July 7, 2020
Record last verified: 2020-07