A Study of PRA052 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2024-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAD Cohorts 1-8 Experimental Arm

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

Group Type EXPERIMENTAL

PRA052

Intervention Type DRUG

PRA052

SAD Cohorts 1-8 Placebo Arm

Subjects will receive a single intravenous or subcutaneous dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

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

Group Type EXPERIMENTAL

PRA052

Intervention Type DRUG

PRA052

MAD Cohorts 1-5 Placebo Arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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PRA052

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes