| Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis |
| A Phase 1, Randomized, Multi-center, Double-blind, Sponsor Open, Placebo-controlled, Single And Multiple Dose-escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis |
| This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites. |
| Not Provided |
| Interventional |
| Phase 1 |
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science |
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
|
- Drug: PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
- Drug: Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
|
- Experimental: Part A, Cohort 1
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 2
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 3
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 4
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 5
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 6
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 7
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 8
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 1
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 2
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 3
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 4
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 5
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, cohort 6
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
|
| Not Provided |
| |
| Recruiting |
| 112 |
| November 15, 2021 |
| November 15, 2021 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR criteria with symptom duration at least 6 months and positive with Rheumatoid Factor and/or anti citrullinated peptide antibody
- Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC Classification Criteria with symptom duration at least 6 months and at least one of the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith antibodies
Exclusion Criteria:
- Active central nervous system manifestations, systemic vasculitis or pleuro/pericarditis
- Active lupus nephritis
- Treatment with B cell depleting agents within 52 weeks prior to screening
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 70 Years (Adult, Senior) |
| No |
|
| United States |
| |
| |
| NCT03334851 |
C1131001
2017-003077-34 ( EudraCT Number ) |
| No |
| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
|
|
|
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| December 2017 |
