A Study of PRA052 in Healthy Volunteers
Study Details
Study Description
Brief Summary
This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA052 in healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SAD Cohorts 1-8 Experimental Arm Subjects will receive a single intravenous or subcutaneous dose of PRA052 in a dose escalation format |
Drug: PRA052
PRA052
|
| Placebo Comparator: SAD Cohorts 1-8 Placebo Arm Subjects will receive a single intravenous or subcutaneous dose of placebo |
Other: Placebo
Placebo
|
| Experimental: MAD Cohorts 1-5 Experimental Arm Subjects will receive three subcutaneous or intravenous doses of PRA052, one dose every 2 weeks, in a dose escalation format |
Drug: PRA052
PRA052
|
| Placebo Comparator: MAD Cohorts 1-5 Placebo Arm Subjects will receive three subcutaneous or intravenous doses of placebo, one dose every 2 weeks |
Other: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Treatment emergent adverse events [Up to 20 weeks]
Incidence, severity, and causal relationship of TEAEs
Secondary Outcome Measures
- Cmax [Up to 20 weeks]
Maximum concentration after single and multiple ascending doses
- Tmax [Up to 20 weeks]
Time to reach maximum concentration after single and multiple ascending doses
- t1/2 [Up to 20 weeks]
Half life after single and multiple ascending doses
- F% [Up to 20 weeks]
Bioavailability after SC injection
- ADA [Up to 20 weeks]
Incidence of anti-drug antibody after single and multiple ascending doses
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 60 years of age.
-
Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 12 weeks after the end of dosing.
-
Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration
Exclusion Criteria:
-
History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
-
Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic, heart rate 40-99 beats/min.
-
12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 120 milliseconds (msec), or QTcF interval of > 450 msec for men or
470 msec for women.
-
Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
-
Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
-
History of or current active tuberculosis (TB) infection; history of latent TB that has not been fully treated or current latent TB infection as indicated by a positive QuantiFERON-TB test.
-
History of significant allergy to any medication as judged by the Investigator.
-
History of alcohol or drug abuse within the past 24 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prometheus Clinical Site | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Prometheus Biosciences, Inc.
Investigators
- Study Chair: Prometheus Biosciences, Inc., Prometheus Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PR600-101