A Study of PRA023 in Healthy Volunteers

NCT04676178 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: PR200-1017240-003
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events

  Incidence, severity, and causal relationship of TEAEs

  Up to 22 weeks

Secondary Outcomes (5)

• Cmax

  Up to 22 weeks

• Tmax

  Up to 22 weeks

• t1/2

  Up to 22 weeks

• AUC

  Up to 22 weeks

• ADA

  Up to 22 weeks

Study Arms (4)

SAD Cohorts 1-6 Experimental Arm

EXPERIMENTAL

Subjects will receive single intravenous doses of PRA023 in a dose escalation format

Drug: PRA023

SAD Cohorts 1-6 Placebo Arm

PLACEBO COMPARATOR

Subjects will receive intravenous doses of placebo

Other: Placebo

MAD Cohorts 1-5 Experimental Arm

EXPERIMENTAL

Subjects will receive three intravenous doses of PRA023, one dose every 2 weeks, in a dose escalation format

Drug: PRA023

MAD Cohorts 1-5 Placebo Arm

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

PRA023 DRUG

PRA023

MAD Cohorts 1-5 Experimental Arm; SAD Cohorts 1-6 Experimental Arm

Placebo OTHER

Placebo

MAD Cohorts 1-5 Placebo Arm; SAD Cohorts 1-6 Placebo Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy, or;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• Celerion: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Allison Luo, MD

  Prometheus Biosciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 19, 2020
• Study Start: December 15, 2020
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)