Healthy SubjectsPhase 1NCT04146129
A Phase 1 Study of CDX-0159
A Phase 1 study testing CDX-0159 and Normal saline in people with Healthy Subjects, run by Celldex Therapeutics at 1 site in United States.
Trial summary
This is a study to determine the safety of CDX-0159 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CDX-0159 and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 26 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
- Other Protocol defined inclusion and exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: 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
This is a study to determine the safety of CDX-0159 in healthy subjects.
Read the detailed description
CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.
This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- CDX-0159, Normal saline
- Keywords
- CDX-0159
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-0159Drug
Single dose of one of four dosages of CDX-0159
Normal salineDrug
Single infusion of normal saline
| Study group | Role | What they receive |
|---|---|---|
| CDX-0159 | Experimental | Eligible subjects will receive a single dose of CDX-0159 Receives: Drug: CDX-0159 |
| Normal saline | Placebo comparator | Subjects assigned to receive placebo will receive a single dose of normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 43.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start29 Oct 2019
- Primary completion6 Apr 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146129
- Sponsor's protocol ID
- CDX0159-01
- Status last verified
- Jul 2020
- First submitted
- 29 Oct 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04146129
- Acronym / sponsor ID
- CDX0159-01
- Conditions
- Healthy Subjects
- Keywords
- CDX-0159
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the safety of CDX-0159 in healthy subjects.
Detailed description
CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.
This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDX-0159 | Experimental | Drug: CDX-0159Eligible subjects will receive a single dose of CDX-0159 |
| Normal saline | Placebo comparator | Drug: Normal salineSubjects assigned to receive placebo will receive a single dose of normal saline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDX-0159Single dose of one of four dosages of CDX-0159 | Drug | CDX-0159 |
| Normal salineSingle infusion of normal saline | Drug | Normal saline |
Primary outcome
Safety as assessed by CTCAE v5.0
Time frame: Day 1 to Day 43.
Safety of single, ascending doses of CDX-0159 as determined by percentage of participants with adverse events as assessed by CTCAE v5.0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDX-0159 and Normal saline in people with Healthy Subjects, run by Celldex Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by CTCAE v5.0 (time frame: Day 1 to Day 43.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.