A Study of PRA052 in Healthy Volunteers

Prometheus Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PRA052; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05603182

MK-8690-001 (Other Identifier)

PR600-101

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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96 participants in 4 patient groups, including a placebo group

SAD Cohorts 1-8 Experimental Arm

Experimental group

Description:

Subjects will receive a single intravenous or subcutaneous dose of PRA052 in a dose escalation format

Treatment:

Drug: PRA052

SAD Cohorts 1-8 Placebo Arm

Placebo Comparator group

Description:

Subjects will receive a single intravenous or subcutaneous dose of placebo

Treatment:

Other: Placebo

MAD Cohorts 1-5 Experimental Arm

Experimental group

Description:

Subjects will receive three subcutaneous or intravenous doses of PRA052, one dose every 2 weeks, in a dose escalation format

Treatment:

Drug: PRA052

MAD Cohorts 1-5 Placebo Arm

Placebo Comparator group

Description:

Subjects will receive three subcutaneous or intravenous doses of placebo, one dose every 2 weeks

Treatment:

Other: Placebo