A Study of PRA023 in Healthy Volunteers | NCT04676178

NCT04676178

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
7240-003	Other Identifier	Merck

Status Module

Name	Class
Celerion	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PRA023	Drug	PRA023	MAD Cohorts 1-5 Experimental Arm SAD Cohorts 1-6 Experimental Arm

Outcomes Module

Measure	Description	Time Frame
Treatment emergent adverse events	Incidence, severity, and causal relationship of TEAEs	Up to 22 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cmax	Maximum concentration after single and multiple ascending doses	Up to 22 weeks
Tmax	Time to reach maximum concentration after single and multiple ascending doses

Eligibility Module

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.