A Study of PRA023 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Drug: PRA023

• Registration Number: NCT04676178
• Lead Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief Summary

This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-09
• Study Start: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 55 years of age.

• Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:

  1. hysteroscopic sterilization;
  2. bilateral tubal ligation or bilateral salpingectomy;
  3. hysterectomy;
  4. bilateral oophorectomy, or;
  5. be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per investigator judgment.

• Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days 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, 60-90 mmHg diastolic, heart rate 60-100 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD Cohorts 1-6 Placebo Arm	Placebo	Subjects will receive intravenous doses of placebo
MAD Cohorts 1-5 Placebo Arm	Placebo	Subjects will receive three intravenous doses of placebo, one dose every 2 weeks,
SAD Cohorts 1-6 Experimental Arm	PRA023	Subjects will receive single intravenous doses of PRA023 in a dose escalation format
MAD Cohorts 1-5 Experimental Arm	PRA023	Subjects will receive three intravenous doses of PRA023, one dose every 2 weeks, in a dose escalation format

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	Up to 22 weeks	Incidence, severity, and causal relationship of TEAEs

Secondary Outcome Measures

Name	Time	Method
Tmax	Up to 22 weeks	Time to reach maximum concentration after single and multiple ascending doses
Cmax	Up to 22 weeks	Maximum concentration after single and multiple ascending doses
ADA	Up to 22 weeks	Incidence of anti-drug antibody after single and multiple ascending doses
t1/2	Up to 22 weeks	Half life after single and multiple ascending doses
AUC	Up to 22 weeks	Area under the curve after single and multiple ascending doses

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States