Overview

A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants

Status:
Completed
Trial end date:
2016-01-12
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
Inclusion Criteria:

- Participants must be a healthy man or woman with no clinically significant
abnormalities on the basis of physical examination, medical history, vital signs, and
12-lead electrocardiogram (ECG) performed at Screening

- Participants must be otherwise healthy on the basis of clinical laboratory tests
performed at Screening. If the results of the serum chemistry panel, hematology, or
urinalysis are outside the normal reference ranges, the subject may be included only
if the investigator judges the abnormalities or deviations from normal to be not
clinically significant or to be appropriate and reasonable for the population under
study. This determination must be recorded in the participant's source documents and
initialed by the investigator

- Have a weight in the range of 60.0 kilogram (kg) to 100.0 kg, inclusive, if male; have
a weight in the range of 50.0 kg to 90.0 kg, inclusive, if female. Have a body mass
index of 18.5 kilogram per meter^2 (kg/m^2) to 30.0 kg/m^2, inclusive

- A woman must have a negative serum (beta human chorionic gonadotropin [beta hCG]) test
at Screening and on Day -1

- Before drug administration, a woman must be either not of childbearing potential (Not
of childbearing potential: Premenarchal; postmenopausal (greater than 45 years of age
with amenorrhea for at least 12 months, or any age with amenorrhea for at least 6
months and a serum follicle stimulating hormone (FSH) level > 40 international Units/
Liter); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
salpingectomy); or otherwise be incapable of pregnancy) OR of childbearing potential
and practicing a highly effective method of birth control consistent with local
regulations regarding the use of birth control methods for subjects participating in
clinical studies (established use of oral, injected or implanted hormonal methods of
contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS);
barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive
cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner
should be the sole partner for that participant); true abstinence [when this is in
line with the preferred and usual lifestyle of the participant])

Exclusion Criteria:

- Participant currently has or has a history of any clinically significant medical
illness or medical disorders the investigator considers should exclude the subject,
including (but not limited to), neuromuscular, hematological disease, immune
deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease,
neurological or psychiatric disease, ophthalmological disorders, neoplastic disease,
renal or urinary tract diseases, or dermatological disease

- Participant is currently undergoing or has previously undergone allergy immunotherapy
for a history of anaphylactic reactions

- Participant has had major surgery (eg, requiring general anesthesia) within 8 weeks
before screening, or will not have fully recovered from surgery, or has surgery
planned during the time the participant is expected to participate in the study (16
weeks)

- Participant has previously received guselkumab

- Participant has received an investigational drug (including investigational vaccines)
or used an invasive investigational medical device within 3 months or 5 half-lives
(whichever is longer) before the study drug administration