NCT04676178CompletedPhase 1
A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA023 in Healthy Volunteers
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 site in 1 country69 target enrollmentStarted: December 15, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Treatment emergent adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •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.
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.
Arms & Interventions
SAD Cohorts 1-6 Experimental Arm
Experimental
Subjects will receive single intravenous doses of PRA023 in a dose escalation format
Intervention: PRA023 (Drug)
SAD Cohorts 1-6 Placebo Arm
Placebo Comparator
Subjects will receive intravenous doses of placebo
Intervention: Placebo (Other)
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
Intervention: PRA023 (Drug)
MAD Cohorts 1-5 Placebo Arm
Placebo Comparator
Subjects will receive three intravenous doses of placebo, one dose every 2 weeks,
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Treatment emergent adverse events
Time Frame: Up to 22 weeks
Incidence, severity, and causal relationship of TEAEs
Secondary Outcomes
- AUC(Up to 22 weeks)
- Tmax(Up to 22 weeks)
- Cmax(Up to 22 weeks)
- ADA(Up to 22 weeks)
- t1/2(Up to 22 weeks)
Investigators
Study Sites (1)
Loading locations...
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