A Study of PRA052 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05603182
• Other study ID #: PR600-101
• Secondary ID: MK-8690-001
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2022
• Est. completion date: February 21, 2024

Study information

• Verified date: March 2024
• Source: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PRA052
PRA052

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Prometheus Clinical Site	Lincoln	Nebraska

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events	Incidence, severity, and causal relationship of TEAEs	Up to 20 weeks
Secondary	Cmax	Maximum concentration after single and multiple ascending doses	Up to 20 weeks
Secondary	Tmax	Time to reach maximum concentration after single and multiple ascending doses	Up to 20 weeks
Secondary	t1/2	Half life after single and multiple ascending doses	Up to 20 weeks
Secondary	F%	Bioavailability after SC injection	Up to 20 weeks
Secondary	ADA	Incidence of anti-drug antibody after single and multiple ascending doses	Up to 20 weeks

External Links

•   Merck Clinical Trials Information