Clinical trial NCT04676178: A Study of PRA023 in Healthy Volunteers
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA023 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2020-12-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: Up to 22 weeks
Secondary outcomes:
measure: Cmax
timeFrame: Up to 22 weeks
measure: Tmax
timeFrame: Up to 22 weeks
measure: t1/2
timeFrame: Up to 22 weeks
measure: AUC
timeFrame: Up to 22 weeks
measure: ADA
timeFrame: Up to 22 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Prometheus Biosciences
name: Allison Luo, MD
role: STUDY_CHAIR
References: