Healthy
Conditions
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.
Interventions
DRUGPRA023
PRA023
OTHERPlacebo
Placebo
Sponsors
Celerion
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events | Up to 22 weeks | Incidence, severity, and causal relationship of TEAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to 22 weeks | Maximum concentration after single and multiple ascending doses |
| Tmax | Up to 22 weeks | Time to reach maximum concentration 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 |
| ADA | Up to 22 weeks | Incidence of anti-drug antibody after single and multiple ascending doses |
Countries
United States
Outcome results
None listed