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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
PRO-203
DrugPRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.
Placebo
Other interventionMatching placebo comparator for Part 1 participants.
Treatment groups
44 Participants
are divided into 3 treatment groupsGroup A: Part 1: PRO-203Experimental treatment 1 intervention
Group B: Part 1: PlaceboPlacebo comparator 1 intervention
Group C: Part 2: Multiple Doses of PRO-203Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events and Laboratory Abnormalities [Safety and Tolerability]
Incidence and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities, including changes in clinical laboratory values, ECGs, and vital signs.
Time frame
13 weeks (Part 1) / 49 weeks (Part 2)Secondary outcomes
1
Pharmacokinetics of PRO-203
Serum drug levels of PRO-203 over time
Time frame
13 weeks (Part 1) / 49 weeks (Part 2)2
Pharmacodynamic-related biomarkers of PRO-203
Peripheral blood B lymphocyte levels over time
Time frame
13 weeks (Part 1) / 49 weeks (Part 2)3
Immunogenicity of PRO-203
Level of anti-drug antibodies
Time frame
13 weeks (Part 1) / 49 weeks (Part 2)Other outcomes
1
Modified Rodnan Skin Score (mRSS) (Part 2)
Change from baseline in Modified Rodnan Skin Score (mRSS) on a scale of 0 to 51, with a higher score indicating greater skin thickening.
Time frame
13 weeks /49 weeks2
Revised Composite Response Index in Systemic Sclerosis (rCRISS) (Part 2)
Change from baseline in disease response as measured by the Revised Composite Response Index in Systemic Sclerosis (rCRISS), where a higher score indicates a better outcome.
Time frame
13 weeks / 49 weeks3
European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) (Part 2)
Change from baseline in disease activity as measured by the European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) on a scale of 0 to 10, where a higher score indicates greater disease activity.
Time frame
13 weeks / 49 weeks4
FVC % Predicted (Part 2)
Change from baseline in forced vital capacity (FVC) as a percentage of predicted normal.
Time frame
13 weeks / 49 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov