TransplantationPhase 1NCT00569803

Subcutaneous Pharmacokinetics of Belatacept

A Phase 1 study testing belatacept in people with Transplantation, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Transplantation
What is being tested?: belatacept
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 153 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Aug 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men and women ages 18 to 65 years old
Subjects must weigh less than or equal to 100 kg

Who cannot join

Inability to tolerate injections or IV infusions
autoimmune disorders
TB
herpes
HCV
HBV

Show all 9Show fewer

HIV
bacterial or viral infection
history of cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

Ppd Development
Austin, Texas, 78744

Other trials in United States

About this study

Official title: Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Conditions: Transplantation
Being tested: belatacept, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

belataceptDrug
single dose, 116 days
PlaceboDrug
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)

Study groups in NCT00569803
Study group	Role	What they receive
Belatacept 50 mg Subcutaneous Injection	Active comparator	Belatacept 50 mg subcutaneous (SC) injection Receives: Drug: belatacept
Belatacept 100 mg Subcutaneous Injection	Active comparator	Belatacept 100 mg SC injection Receives: Drug: belatacept
Belatacept 125 mg Subcutaneous Injection	Active comparator	Belatacept 125 mg SC injection Receives: Drug: belatacept
Belatacept 150 mg Subcutaneous Injections	Active comparator	2 SC injections of 75 mg Belatacept Receives: Drug: belatacept
Belatacept 200 mg Subcutaneous Injections	Active comparator	2 SC injections of 100 mg Belatacept Receives: Drug: belatacept
Belatacept 250 mg Subcutaneous Injections	Active comparator	2 SC injections of 125 mg Belatacept Receives: Drug: belatacept
Belatacept 125 mg Intravenous Infusion	Active comparator	125 mg Belatacept intravenous (IV) injection Receives: Drug: belatacept
Placebo	Placebo comparator	SC injection of placebo solution Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Serum Concentration (Cmax) of Belatacept
Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Time of Maximum Observed Serum Concentration (Tmax) of Belatacept
Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL).
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL)
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Serum Half-life (T-HALF) of Belatacept
Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Apparent Total Body Clearance (CLT/F) of SC Belatacept
Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Total Body Clearance (CLT) of IV Belatacept
Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Volume of Distribution at Steady State (VSS) for IV Belatacept
Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept
Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116

Secondary outcomes (9)

Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption
AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug*h/mL).
AUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration.
AUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time.
Measured: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Number of Participants With Vital Sign Abnormalities
Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.
Measured: 1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116
Number of Participants With Injection Site Reactions
Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.
Measured: 0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116
Number of Participants With Physical Examination Abnormalities
All clinically significant deviations from normal physical examinations were reported.
Measured: Days 1, 2, 5, 14, 28, 42, 86, 116
Number of Participants With Electrocardiogram (ECG) Abnormalities
Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.
Measured: Days 1 and 116
Number of Participants With Marked Hematology Laboratory Abnormalities
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:
Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (*10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx).
Leukocytes (*10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre-Rx>ULN, use >1.15*Pre-Rx or <LLN) Neutrophils+Bands (*10^3 c/uL): <=1.500. Lymphocytes (*10^3 c/uL): <0.750 or >7.500. Monocytes (*10^3 c/uL): >2.000. Basophils (*10^3 c/uL): >0.400. Eosinophils (*10^3 c/uL): >0.750.
Measured: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Number of Participants With Marked Serum Chemistry Abnormalities
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:
Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).
Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).
Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (mg/dL): >1.33*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): <0.95*LLN, >1.05*ULN (if Pre-Rx<LLN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN).
Potassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).
Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN).
Measured: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Number of Participants With Marked Laboratory Abnormalities
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:
Glucose (mg/dL): <0.8*LLN, >1.5*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN).
Protein (grams per deciliter: g/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).
Albumin (g/dL): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mg.dL): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)
Measured: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Number of Participants With Positive Immunogenicity to Belatacept
The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.
Measured: Days 1, 14, 28, 42, 56, 86, 116

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Aug 2008

First posted7 Dec 2007 (estimated)
Study startDec 2007
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TransplantationStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00569803
Sponsor's protocol ID: IM103-046
Status last verified: Aug 2016
First submitted: 30 Nov 2007
Last updated: 22 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)

All Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects
ClinicalTrials.gov ID: NCT00569803
Acronym / sponsor ID: IM103-046
Conditions: Transplantation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 7 Dec 2007 (estimated)
Results: Posted 15 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
Belatacept 50 mg Subcutaneous Injection	Active comparator	Drug: belataceptBelatacept 50 mg subcutaneous (SC) injection
Belatacept 100 mg Subcutaneous Injection	Active comparator	Drug: belataceptBelatacept 100 mg SC injection
Belatacept 125 mg Subcutaneous Injection	Active comparator	Drug: belataceptBelatacept 125 mg SC injection
Belatacept 150 mg Subcutaneous Injections	Active comparator	Drug: belatacept2 SC injections of 75 mg Belatacept
Belatacept 200 mg Subcutaneous Injections	Active comparator	Drug: belatacept2 SC injections of 100 mg Belatacept
Belatacept 250 mg Subcutaneous Injections	Active comparator	Drug: belatacept2 SC injections of 125 mg Belatacept
Belatacept 125 mg Intravenous Infusion	Active comparator	Drug: belatacept125 mg Belatacept intravenous (IV) injection
Placebo	Placebo comparator	Drug: PlaceboSC injection of placebo solution

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men and women ages 18 to 65 years old
Subjects must weigh less than or equal to 100 kg

Key exclusion criteria (9 listed)

Inability to tolerate injections or IV infusions
autoimmune disorders
TB
herpes
HCV

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
belataceptsingle dose, 116 days	Drug	Belatacept 100 mg Subcutaneous Injection, Belatacept 125 mg Intravenous Infusion, Belatacept 125 mg Subcutaneous Injection, Belatacept 150 mg Subcutaneous Injections, Belatacept 200 mg Subcutaneous Injections, Belatacept 250 mg Subcutaneous Injections, Belatacept 50 mg Subcutaneous Injection
PlaceboSubcutaneous injection of placebo solution (product ID: 224818-N000- 029)	Drug	Placebo

Primary outcome

Maximum Observed Serum Concentration (Cmax) of Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).
Time of Maximum Observed Serum Concentration (Tmax) of Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL).
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL)
Serum Half-life (T-HALF) of Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.
Apparent Total Body Clearance (CLT/F) of SC Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).
Total Body Clearance (CLT) of IV Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)
Volume of Distribution at Steady State (VSS) for IV Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.
Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.

9 secondary outcomes

Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption
Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Number of Participants With Vital Sign Abnormalities
Time frame: 1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116
Number of Participants With Injection Site Reactions
Time frame: 0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116
Number of Participants With Physical Examination Abnormalities
Time frame: Days 1, 2, 5, 14, 28, 42, 86, 116
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: Days 1 and 116
Number of Participants With Marked Hematology Laboratory Abnormalities
Time frame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Number of Participants With Marked Serum Chemistry Abnormalities
Time frame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Number of Participants With Marked Laboratory Abnormalities
Time frame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Number of Participants With Positive Immunogenicity to Belatacept
Time frame: Days 1, 14, 28, 42, 56, 86, 116

Results and safety

Results posted to the registry on 15 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Belatacept 50 mg Subcutaneous Injection	5	4
Belatacept 100 mg Subcutaneous Injection	5	5
Belatacept 125 mg Subcutaneous Injection	5	5
Belatacept 150 mg Subcutaneous Injections	6	5
Belatacept 200 mg Subcutaneous Injections	5	5
Belatacept 250 mg Subcutaneous Injections	5	5
Belatacept 125 mg Intravenous Infusion	10	10
Placebo	6	5

Primary outcome: Maximum Observed Serum Concentration (Cmax) of Belatacept

Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116. Geometric mean (Geometric Coefficient of Variation). Unit: ug/mL

Measure	Belatacept 50 mg Subcutaneous Injection n = 5	Belatacept 100 mg Subcutaneous Injection n = 5	Belatacept 125 mg Subcutaneous Injection n = 5	Belatacept 150 mg Subcutaneous Injections n = 5	Belatacept 200 mg Subcutaneous Injections n = 5	Belatacept 250 mg Subcutaneous Injections n = 5	Belatacept 125 mg Intravenous Infusion n = 10
Value	3.9 (30)	6.2 (34)	8.5 (50)	11.1 (19)	14.5 (16)	14.5 (18)	42.4 (16)

Population analysed: All participants treated with Belatacept

Primary outcome: Time of Maximum Observed Serum Concentration (Tmax) of Belatacept

Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116. Median (Full Range). Unit: hours

Measure	Belatacept 50 mg Subcutaneous Injection n = 5	Belatacept 100 mg Subcutaneous Injection n = 5	Belatacept 125 mg Subcutaneous Injection n = 5	Belatacept 150 mg Subcutaneous Injections n = 5	Belatacept 200 mg Subcutaneous Injections n = 5	Belatacept 250 mg Subcutaneous Injections n = 5	Belatacept 125 mg Intravenous Infusion n = 10
Value	84 (36 to 96)	60 (48 to 120)	96 (48 to 144)	60 (36 to 96)	60 (24 to 84)	72 (60 to 96)	0.5 (0.2 to 2.0)

Population analysed: All participants treated with Belatacept

Primary outcome: Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept

Time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116. Geometric mean (90% Confidence Interval). Unit: ug*h/mL

Measure	Belatacept 50 mg Subcutaneous Injection n = 5	Belatacept 100 mg Subcutaneous Injection n = 5	Belatacept 125 mg Subcutaneous Injection n = 5	Belatacept 150 mg Subcutaneous Injections n = 5	Belatacept 200 mg Subcutaneous Injections n = 5	Belatacept 250 mg Subcutaneous Injections n = 5	Belatacept 125 mg Intravenous Infusion n = 10
Value	2587 (2132 to 3139)	1848 (1523 to 2242)	2371 (1954 to 2876)	2703 (2228 to 3280)	2650 (2184 to 3215)	2193 (1807 to 2660)	3023 (2637 to 3466)

Belatacept 50 mg Subcutaneous Injection vs Belatacept 125 mg Intravenous Infusion: Ratio of Geometric Means: 0.86 (90% CI 0.68 to 1.08)
Belatacept 100 mg Subcutaneous Injection vs Belatacept 125 mg Intravenous Infusion: Ratio of Geometric Means: 0.61 (90% CI 0.48 to 0.77)
Belatacept 125 mg Subcutaneous Injection vs Belatacept 125 mg Intravenous Infusion: Ratio of Geometric Means: 0.78 (90% CI 0.62 to 0.99)

Population analysed: All participants treated with Belatacept

Primary outcome: Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept

Measure	Belatacept 50 mg Subcutaneous Injection n = 5	Belatacept 100 mg Subcutaneous Injection n = 5	Belatacept 125 mg Subcutaneous Injection n = 5	Belatacept 150 mg Subcutaneous Injections n = 5	Belatacept 200 mg Subcutaneous Injections n = 5	Belatacept 250 mg Subcutaneous Injections n = 5	Belatacept 125 mg Intravenous Infusion n = 10
Value	2639 (2172 to 3205)	1851 (1524 to 2248)	2380 (1959 to 2891)	2719 (2238 to 3303)	2666 (2194 to 3238)	2201 (1812 to 2673)	3031 (2642 to 3478)

Belatacept 50 mg Subcutaneous Injection vs Belatacept 125 mg Intravenous Infusion: Ratio of Geometric Means: 0.87 (90% CI 0.69 to 1.10)
Belatacept 100 mg Subcutaneous Injection vs Belatacept 125 mg Intravenous Infusion: Ratio of Geometric Means: 0.61 (90% CI 0.48 to 0.77)
Belatacept 125 mg Subcutaneous Injection vs Belatacept 125 mg Intravenous Infusion: Ratio of Geometric Means: 0.79 (90% CI 0.62 to 1.00)

Population analysed: All participants treated with Belatacept

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belatacept 50mg SC	0 of 5 (0%)	2 of 5 (40%)	Not reported
Belatacept 100mg SC	0 of 5 (0%)	3 of 5 (60%)	Not reported
Belatacept 125mg SC	0 of 5 (0%)	3 of 5 (60%)	Not reported
Belatacept 150mg SC	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Belatacept 200mg SC	0 of 5 (0%)	2 of 5 (40%)	Not reported
Belatacept 250mg SC	0 of 5 (0%)	2 of 5 (40%)	Not reported
Belatacept 125mg IV	0 of 10 (0%)	7 of 10 (70%)	Not reported
PLACEBO	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
All Belatacept	0 of 41 (0%)	23 of 41 (56.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Transplantation

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing belatacept in people with Transplantation, run by Bristol-Myers Squibb at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Concentration (Cmax) of Belatacept (time frame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.