A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorProlium Bioscience, Inc
About this trial
A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).
Eligibility criteria
Qualifiers
Is male or female, age 18 to 65 years, inclusive, at Screening.
Able to provide Informed Consent.
Absolute B cell count > 25 cells/uL.
In good general health, determined by no clinically significant findings in the of the investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 (participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment).
Disqualifiers
Any clinically significant underlying illness in the opinion of the investigator.
Active infection within 4 weeks prior to screening. Participants receiving IV antibiotics or having received IV antibiotics within 14 days prior to enrollment are excluded.
Positive QuantiFERON-Gold TB test at screening.
Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, such as the flu vaccine, are allowed).
Trial design
Treatments tested in this trial
- PRO-203
- Placebo
Treatment groups
44 Participants
are divided into 3 treatment groupsLocations
3Australia
Nucleus Network3004, MelbourneVictoria, Australia
China
Peking University Third Hospital Beijing China
Nanjing Drum Tower Hospital Nanjing China
Sponsors and collaborators
Prolium Bioscience, Inc
Lead sponsor
Source ClinicalTrials.gov