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OpenTrials
Completed

NCT Number: NCT05603182

A Study of PRA052 in Healthy Volunteers

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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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prometheus Clinical Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRA052

Drug

PRA052

Placebo

Other

Placebo

Primary outcomes

  1. Treatment emergent adverse events

    Time frame: Up to 20 weeks

    Incidence, severity, and causal relationship of TEAEs

Secondary outcomes

  1. Cmax

    Time frame: Up to 20 weeks

    Maximum concentration after single and multiple ascending doses

  2. Tmax

    Time frame: Up to 20 weeks

    Time to reach maximum concentration after single and multiple ascending doses

  3. t1/2

    Time frame: Up to 20 weeks

    Half life after single and multiple ascending doses

  4. F%

    Time frame: Up to 20 weeks

    Bioavailability after SC injection

  5. ADA

    Time frame: Up to 20 weeks

    Incidence of anti-drug antibody after single and multiple ascending doses

Sponsors and collaborators

Lead sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA052 in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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