HealthyPhase 1NCT02766621
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
A Phase 1 study testing PF-06823859 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 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
- What is being tested?
- PF-06823859
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2016to 26 Sep 2017
- 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
- Healthy female subjects of non childbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
- Subjects with a history of autoimmune disorders.
- Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: Phase 1, Randomized, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous And Subcutaneous Doses Of Pf-06823859 In Healthy Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.
- Conditions
- Healthy
- Being tested
- PF-06823859, Placebo injection SC/IV
- Keywords
- First in human, Phase 1, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06823859Biological
Also called Study drug
Comparison of different dosages of PF-06823859 to placebo
Placebo injection SC/IVDrug
Also called Placebo
Comparison of Placebo to different doses of PF-06823859
| Study group | Role | What they receive |
|---|---|---|
| Placebo injection SC/IV | Placebo comparator | Placebo for injection SC/IV Receives: Drug: Placebo injection SC/IV |
| PF-06823859 | Active comparator | Study Drug being used in the study Receives: Biological: PF-06823859 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs
Safety
Measured: Dosing through approximately Day 189
Secondary outcomes (14)
Apparent Clearance (CL) of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859
Immunogenicity
Measured: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Maximum Observed Plasma Concentration (Cmax) of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Plasma Decay Half-Life (t1/2)
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Volume of Distribution at Steady State (Vss) of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
AUCtau (dose normalized)
Pharmacokinetics
Measured: Pre dose to approximately Day 189
C av of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Mean residence of time for PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859
Pharmacokinetics
Measured: Pre dose to approximately Day 189
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start27 May 2016
- Primary completion30 Aug 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766621
- Sponsor's protocol ID
- C0251001
- Status last verified
- Nov 2017
- First submitted
- 6 May 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Prybylski JP, Zhu J', Banfield C, Mukherjee A, Purohit V. Early exposure-response modeling of an interferon-beta monoclonal antibody (dazukibart) in adults with dermatomyositis. J Pharmacokinet Pharmacodyn. 2026 Mar 24;53(3):17. doi: 10.1007/s10928-026-10022-1.
PubMed 41874840Neelakantan S, Oemar B, Johnson K, Rath N, Salganik M, Berman G, Pelletier K, Cox L, Page K, Messing D, Tarabar S. Safety, Tolerability, and Pharmacokinetics of PF-06823859, an Anti-Interferon beta Monoclonal Antibody: A Randomized, Phase I, Single- and Multiple-Ascending-Dose Study. Clin Pharmacol Drug Dev. 2021 Mar;10(3):307-316. doi: 10.1002/cpdd.887. Epub 2020 Dec 22.
PubMed 33352008
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous And Subcutaneous Doses Of Pf-06823859 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT02766621
- Acronym / sponsor ID
- C0251001
- Conditions
- Healthy
- Keywords
- First in human, Phase 1, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 May 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 10 May 2016 (estimated)
- 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.
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo injection SC/IV | Placebo comparator | Drug: Placebo injection SC/IVPlacebo for injection SC/IV |
| PF-06823859 | Active comparator | Biological: PF-06823859Study Drug being used in the study |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female subjects of non childbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (3 listed)
- History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
- Subjects with a history of autoimmune disorders.
- Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| PF-06823859Also: Study drugComparison of different dosages of PF-06823859 to placebo | Biological | PF-06823859 |
| Placebo injection SC/IVAlso: PlaceboComparison of Placebo to different doses of PF-06823859 | Drug | Placebo injection SC/IV |
Primary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs
Time frame: Dosing through approximately Day 189
Safety
14 secondary outcomes
Apparent Clearance (CL) of PF-06823859
Time frame: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859
Time frame: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859
Time frame: Pre dose to approximately Day 189
Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859
Time frame: Pre dose to approximately Day 189
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859
Time frame: Pre dose to approximately Day 189
Maximum Observed Plasma Concentration (Cmax) of PF-06823859
Time frame: Pre dose to approximately Day 189
Plasma Decay Half-Life (t1/2)
Time frame: Pre dose to approximately Day 189
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously
Time frame: Pre dose to approximately Day 189
Volume of Distribution at Steady State (Vss) of PF-06823859
Time frame: Pre dose to approximately Day 189
AUCtau (dose normalized)
Time frame: Pre dose to approximately Day 189
C av of PF-06823859
Time frame: Pre dose to approximately Day 189
Mean residence of time for PF-06823859
Time frame: Pre dose to approximately Day 189
Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859
Time frame: Pre dose to approximately Day 189
bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859
Time frame: Pre dose to approximately Day 189
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 17 Nov 2017.
- Derived from this study: PubMed 41874840Prybylski JP, Zhu J', Banfield C, Mukherjee A, Purohit V. Early exposure-response modeling of an interferon-beta monoclonal antibody (dazukibart) in adults with dermatomyositis. J Pharmacokinet Pharmacodyn. 2026 Mar 24;53(3):17. doi: 10.1007/s10928-026-10022-1.
- Derived from this study: PubMed 33352008Neelakantan S, Oemar B, Johnson K, Rath N, Salganik M, Berman G, Pelletier K, Cox L, Page K, Messing D, Tarabar S. Safety, Tolerability, and Pharmacokinetics of PF-06823859, an Anti-Interferon beta Monoclonal Antibody: A Randomized, Phase I, Single- and Multiple-Ascending-Dose Study. Clin Pharmacol Drug Dev. 2021 Mar;10(3):307-316. doi: 10.1002/cpdd.887. Epub 2020 Dec 22.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 PF-06823859 in people with Healthy, run by Pfizer 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 2 inclusion and 3 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 17 Nov 2017. 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?
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs (time frame: Dosing through approximately Day 189). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766621, which also lists 2 linked publications.
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 17 Nov 2017.