NCT03375138

Brief Summary

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

December 13, 2017

Last Update Submit

July 23, 2019

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (2)

  • Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).

    Measured by plasma concentration.

    Up to day 57

  • Maximum observed serum concentration (Cmax).

    Measured by plasma concentration.

    Up to day 57

Secondary Outcomes (7)

  • Incidence of non-serious Adverse Events (AEs).

    Up to 71 days.

  • Incidence of Serious Adverse Events (SAEs).

    Up to 71 days.

  • Incidence of Adverse Events (AEs) leading to discontinuation.

    Up to 71 days.

  • Number of participants with vital sign abnormalities.

    Up to 71 days.

  • Number of participants with physical examination abnormalities.

    Up to 71 days.

  • +2 more secondary outcomes

Study Arms (2)

Process E PPQ belatacept

EXPERIMENTAL

10 mg/kg, single dose by intravenous (IV) infusion.

Drug: belatacept

Process C belatacept

EXPERIMENTAL

10 mg/kg, single dose by intravenous (IV) infusion.

Drug: belatacept

Interventions

belataceptDRUG

Specified dose on specified days

Process C belataceptProcess E PPQ belatacept

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent form.
  • Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
  • Weight between 60.0 to 100.0 kg, inclusive.
  • Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 80 days after treatment ends.
  • Women must not be breastfeeding.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 140 days after treatment ends. In addition, male participants must not donate sperm during this time.

You may not qualify if:

  • Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.
  • History of shingles (herpes zoster).
  • Personal or strong family history of cancer.
  • Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
  • Any known or suspected autoimmune disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PPD Austin Clinic

Austin, Texas, 78744, United States

Location

Covance, Inc.

Dallas, Texas, 75247, United States

Location

Related Links

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 15, 2017

Study Start

December 4, 2017

Primary Completion

May 8, 2018

Study Completion

April 2, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

US(2)