A Study of PRA023 in Healthy Volunteers

Prometheus Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: PRA023

Study type: Interventional

Funder types: Industry

Identifiers

NCT04676178

PR200-101

7240-003 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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69 participants in 4 patient groups, including a placebo group

SAD Cohorts 1-6 Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: PRA023

SAD Cohorts 1-6 Placebo Arm

Placebo Comparator group

Description:

Subjects will receive intravenous doses of placebo

Treatment:

Other: Placebo

MAD Cohorts 1-5 Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: PRA023

MAD Cohorts 1-5 Placebo Arm

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo