Transplantation
Conditions
Brief summary
Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects
Interventions
DRUGbelatacept
single dose, 116 days
DRUGPlacebo
Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women ages 18 to 65 years old * Subjects must weigh less than or equal to 100 kg
Exclusion criteria
* Inability to tolerate injections or IV infusions * autoimmune disorders * TB * herpes * HCV * HBV * HIV * bacterial or viral infection * history of cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept | 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. |
| Maximum Observed Serum Concentration (Cmax) of Belatacept | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption | 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 | 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. |
| Number of Participants With Vital Sign Abnormalities | 1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116 | 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. |
| Number of Participants With Injection Site Reactions | 0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116 | 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. |
| Number of Participants With Physical Examination Abnormalities | Days 1, 2, 5, 14, 28, 42, 86, 116 | All clinically significant deviations from normal physical examinations were reported. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Days 1 and 116 | Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported. |
| Number of Participants With Marked Hematology Laboratory Abnormalities | Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116 | 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. |
| Number of Participants With Marked Serum Chemistry Abnormalities | Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116 | 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). |
| Number of Participants With Marked Laboratory Abnormalities | Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116 | 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) |
| Number of Participants With Positive Immunogenicity to Belatacept | Days 1, 14, 28, 42, 56, 86, 116 | 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. |
Countries
United States
Participant flow
Pre-assignment details
153 participants were enrolled, with 106 discontinuing prior to study drug administration because they no longer met study criteria or they withdrew consent. 47 participants met all eligibility criteria and received study medication. 1 subject, who received an incomplete dose due to an injection syringe leak, was replaced.
Participants by arm
| Arm | Count |
|---|---|
| Belatacept 50 mg Subcutaneous Injection Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume | 5 |
| Belatacept 100 mg Subcutaneous Injection Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume | 5 |
| Belatacept 125 mg Subcutaneous Injection Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume | 5 |
| Belatacept 150 mg Subcutaneous Injections Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection. | 6 |
| Belatacept 200 mg Subcutaneous Injections Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection. | 5 |
| Belatacept 250 mg Subcutaneous Injections Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection. | 5 |
| Belatacept 125 mg Intravenous Infusion 125 mg Belatacept intravenous (IV) injection | 10 |
| Placebo Subcutaneous injection of placebo solution (product ID: 224818-N000- 029) | 6 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | injection syringe leaked during dosing | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Belatacept 50 mg Subcutaneous Injection | Belatacept 100 mg Subcutaneous Injection | Belatacept 125 mg Subcutaneous Injection | Belatacept 150 mg Subcutaneous Injections | Belatacept 200 mg Subcutaneous Injections | Belatacept 250 mg Subcutaneous Injections | Belatacept 125 mg Intravenous Infusion | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 11 | 27 years STANDARD_DEVIATION 12 | 28 years STANDARD_DEVIATION 12 | 34 years STANDARD_DEVIATION 18 | 31 years STANDARD_DEVIATION 11 | 31 years STANDARD_DEVIATION 10 | 32 years STANDARD_DEVIATION 16 | 27 years STANDARD_DEVIATION 6 | 30 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 21 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 8 Participants | 2 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 5 | 3 / 5 | 3 / 5 | 4 / 6 | 2 / 5 | 2 / 5 | 7 / 10 | 1 / 6 | 23 / 41 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 10 | 0 / 6 | 0 / 41 |
Outcome results
Primary
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)
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
Population: All participants treated with Belatacept
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept | 2639 ug*h/mL |
| Belatacept 100 mg Subcutaneous Injection | Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept | 1851 ug*h/mL |
| Belatacept 125 mg Subcutaneous Injection | Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept | 2380 ug*h/mL |
| Belatacept 150 mg Subcutaneous Injections | Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept | 2719 ug*h/mL |
| Belatacept 200 mg Subcutaneous Injections | Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept | 2666 ug*h/mL |
| Belatacept 250 mg Subcutaneous Injections | Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept | 2201 ug*h/mL |
| Belatacept 125 mg Intravenous Infusion | Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept | 3031 ug*h/mL |
90% CI: [0.69, 1.1]
90% CI: [0.48, 0.77]
90% CI: [0.62, 1]
90% CI: [0.71, 1.14]
90% CI: [0.69, 1.12]
90% CI: [0.57, 0.92]
Primary
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).
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
Population: All participants treated with Belatacept
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | 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 | 2587 ug*h/mL |
| Belatacept 100 mg Subcutaneous Injection | 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 | 1848 ug*h/mL |
| Belatacept 125 mg Subcutaneous Injection | 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 | 2371 ug*h/mL |
| Belatacept 150 mg Subcutaneous Injections | 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 | 2703 ug*h/mL |
| Belatacept 200 mg Subcutaneous Injections | 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 | 2650 ug*h/mL |
| Belatacept 250 mg Subcutaneous Injections | 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 | 2193 ug*h/mL |
| Belatacept 125 mg Intravenous Infusion | 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 | 3023 ug*h/mL |
90% CI: [0.68, 1.08]
90% CI: [0.48, 0.77]
90% CI: [0.62, 0.99]
90% CI: [0.71, 1.13]
90% CI: [0.69, 1.11]
90% CI: [0.57, 0.92]
Primary
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).
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
Population: All participants treated with SC Belatacept
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Apparent Total Body Clearance (CLT/F) of SC Belatacept | 47.4 mL/h | Geometric Coefficient of Variation 27 |
| Belatacept 100 mg Subcutaneous Injection | Apparent Total Body Clearance (CLT/F) of SC Belatacept | 67.5 mL/h | Geometric Coefficient of Variation 34 |
| Belatacept 125 mg Subcutaneous Injection | Apparent Total Body Clearance (CLT/F) of SC Belatacept | 52.5 mL/h | Geometric Coefficient of Variation 31 |
| Belatacept 150 mg Subcutaneous Injections | Apparent Total Body Clearance (CLT/F) of SC Belatacept | 46.0 mL/h | Geometric Coefficient of Variation 26 |
| Belatacept 200 mg Subcutaneous Injections | Apparent Total Body Clearance (CLT/F) of SC Belatacept | 46.9 mL/h | Geometric Coefficient of Variation 21 |
| Belatacept 250 mg Subcutaneous Injections | Apparent Total Body Clearance (CLT/F) of SC Belatacept | 56.8 mL/h | Geometric Coefficient of Variation 20 |
Primary
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.
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
Population: All participants treated with SC Belatacept
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept | 10.79 Liters | Geometric Coefficient of Variation 31.02 |
| Belatacept 100 mg Subcutaneous Injection | Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept | 15.30 Liters | Geometric Coefficient of Variation 28.79 |
| Belatacept 125 mg Subcutaneous Injection | Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept | 14.12 Liters | Geometric Coefficient of Variation 36.63 |
| Belatacept 150 mg Subcutaneous Injections | Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept | 12.75 Liters | Geometric Coefficient of Variation 14.2 |
| Belatacept 200 mg Subcutaneous Injections | Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept | 13.34 Liters | Geometric Coefficient of Variation 13.77 |
| Belatacept 250 mg Subcutaneous Injections | Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept | 15.82 Liters | Geometric Coefficient of Variation 11.92 |
Primary
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).
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
Population: All participants treated with Belatacept
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Maximum Observed Serum Concentration (Cmax) of Belatacept | 3.9 ug/mL | Geometric Coefficient of Variation 30 |
| Belatacept 100 mg Subcutaneous Injection | Maximum Observed Serum Concentration (Cmax) of Belatacept | 6.2 ug/mL | Geometric Coefficient of Variation 34 |
| Belatacept 125 mg Subcutaneous Injection | Maximum Observed Serum Concentration (Cmax) of Belatacept | 8.5 ug/mL | Geometric Coefficient of Variation 50 |
| Belatacept 150 mg Subcutaneous Injections | Maximum Observed Serum Concentration (Cmax) of Belatacept | 11.1 ug/mL | Geometric Coefficient of Variation 19 |
| Belatacept 200 mg Subcutaneous Injections | Maximum Observed Serum Concentration (Cmax) of Belatacept | 14.5 ug/mL | Geometric Coefficient of Variation 16 |
| Belatacept 250 mg Subcutaneous Injections | Maximum Observed Serum Concentration (Cmax) of Belatacept | 14.5 ug/mL | Geometric Coefficient of Variation 18 |
| Belatacept 125 mg Intravenous Infusion | Maximum Observed Serum Concentration (Cmax) of Belatacept | 42.4 ug/mL | Geometric Coefficient of Variation 16 |
Primary
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.
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
Population: All participants treated with Belatacept
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Serum Half-life (T-HALF) of Belatacept | 112 hours | Standard Deviation 25.7 |
| Belatacept 100 mg Subcutaneous Injection | Serum Half-life (T-HALF) of Belatacept | 100 hours | Standard Deviation 10.1 |
| Belatacept 125 mg Subcutaneous Injection | Serum Half-life (T-HALF) of Belatacept | 135 hours | Standard Deviation 47.6 |
| Belatacept 150 mg Subcutaneous Injections | Serum Half-life (T-HALF) of Belatacept | 158 hours | Standard Deviation 46.9 |
| Belatacept 200 mg Subcutaneous Injections | Serum Half-life (T-HALF) of Belatacept | 161 hours | Standard Deviation 45.3 |
| Belatacept 250 mg Subcutaneous Injections | Serum Half-life (T-HALF) of Belatacept | 150 hours | Standard Deviation 43.6 |
| Belatacept 125 mg Intravenous Infusion | Serum Half-life (T-HALF) of Belatacept | 130 hours | Standard Deviation 27.6 |
Primary
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.
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
Population: All participants treated with Belatacept
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Time of Maximum Observed Serum Concentration (Tmax) of Belatacept | 84 hours |
| Belatacept 100 mg Subcutaneous Injection | Time of Maximum Observed Serum Concentration (Tmax) of Belatacept | 60 hours |
| Belatacept 125 mg Subcutaneous Injection | Time of Maximum Observed Serum Concentration (Tmax) of Belatacept | 96 hours |
| Belatacept 150 mg Subcutaneous Injections | Time of Maximum Observed Serum Concentration (Tmax) of Belatacept | 60 hours |
| Belatacept 200 mg Subcutaneous Injections | Time of Maximum Observed Serum Concentration (Tmax) of Belatacept | 60 hours |
| Belatacept 250 mg Subcutaneous Injections | Time of Maximum Observed Serum Concentration (Tmax) of Belatacept | 72 hours |
| Belatacept 125 mg Intravenous Infusion | Time of Maximum Observed Serum Concentration (Tmax) of Belatacept | 0.5 hours |
Primary
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)
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
Population: All participants treated with IV Belatacept
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Total Body Clearance (CLT) of IV Belatacept | 41.2 mL/h | Geometric Coefficient of Variation 21 |
Primary
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.
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
Population: All participants treated with IV Belatacept
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Volume of Distribution at Steady State (VSS) for IV Belatacept | 7.3 Liters | Standard Deviation 1.27 |
Secondary
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.
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
Population: All participants treated with Belatacept
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption | AUC(0-T) | 898 ug*h/mL |
| Belatacept 50 mg Subcutaneous Injection | Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption | AUC(INF) | 906 ug*h/mL |
| Belatacept 100 mg Subcutaneous Injection | Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption | AUC(0-T) | 1002 ug*h/mL |
| Belatacept 100 mg Subcutaneous Injection | Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption | AUC(INF) | 1007 ug*h/mL |
90% CI: [0.75, 1.07]
90% CI: [0.75, 1.07]
Secondary
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.
Time frame: Days 1 and 116
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 2 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 2 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 1 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 1 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 1 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 1 participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Abnormalities | Screening (Day 1) | 0 participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Abnormalities | Study Discharge (Day 116) | 0 participants |
Secondary
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.
Time frame: 0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | mild reaction | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | moderate reaction | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | moderate reaction | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | mild reaction | 1 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | mild reaction | 1 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Injection Site Reactions | moderate reaction | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | mild reaction | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | moderate reaction | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | moderate reaction | 1 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | mild reaction | 1 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | moderate reaction | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | mild reaction | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Injection Site Reactions | moderate reaction | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Injection Site Reactions | mild reaction | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
| Placebo | Number of Participants With Injection Site Reactions | mild reaction | 0 participants |
| Placebo | Number of Participants With Injection Site Reactions | moderate reaction | 0 participants |
| Placebo | Number of Participants With Injection Site Reactions | severe reaction | 0 participants |
Secondary
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.
Time frame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 1 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 2 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 1 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 1 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Leukocytes | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Monocytes (absolute) | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Hematocrit | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Hemoglobin | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Neutrophils + Bands (absolute) | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Basophils (absolute) | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Platelet Count | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Lymphocytes (absolute) | 0 participants |
| Placebo | Number of Participants With Marked Hematology Laboratory Abnormalities | Eosinophils (absolute) | 0 participants |
Secondary
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)
Time frame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 1 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 1 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
| Placebo | Number of Participants With Marked Laboratory Abnormalities | Albumin | 0 participants |
| Placebo | Number of Participants With Marked Laboratory Abnormalities | Protein, Total | 0 participants |
| Placebo | Number of Participants With Marked Laboratory Abnormalities | Glucose, Fasting Serum | 0 participants |
| Placebo | Number of Participants With Marked Laboratory Abnormalities | Lactate Dehydrogenase | 0 participants |
| Placebo | Number of Participants With Marked Laboratory Abnormalities | Uric Acid | 0 participants |
Secondary
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).
Time frame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 1 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 0 participants |
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 1 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 1 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 1 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 1 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 1 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Phosphorus, Inorganic | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Creatinine | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Calcium, Total | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Aspartate Aminotransferase | 1 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Potassium, Serum | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Alanine Aminotransferase | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Bilirubin | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Blood Urea Nitrogen | 1 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Chloride, Serum | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Alkaline Phosphatase | 0 participants |
| Placebo | Number of Participants With Marked Serum Chemistry Abnormalities | Sodium, Serum | 0 participants |
Secondary
Number of Participants With Physical Examination Abnormalities
All clinically significant deviations from normal physical examinations were reported.
Time frame: Days 1, 2, 5, 14, 28, 42, 86, 116
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Physical Examination Abnormalities | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Physical Examination Abnormalities | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Physical Examination Abnormalities | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Physical Examination Abnormalities | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Physical Examination Abnormalities | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Physical Examination Abnormalities | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Physical Examination Abnormalities | 0 participants |
| Placebo | Number of Participants With Physical Examination Abnormalities | 0 participants |
Secondary
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.
Time frame: Days 1, 14, 28, 42, 56, 86, 116
Population: All participants treated with Belatacept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Positive Immunogenicity to Belatacept | 4 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Positive Immunogenicity to Belatacept | 5 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Positive Immunogenicity to Belatacept | 5 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Positive Immunogenicity to Belatacept | 5 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Positive Immunogenicity to Belatacept | 5 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Positive Immunogenicity to Belatacept | 5 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Positive Immunogenicity to Belatacept | 10 participants |
Secondary
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.
Time frame: 1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belatacept 50 mg Subcutaneous Injection | Number of Participants With Vital Sign Abnormalities | 0 participants |
| Belatacept 100 mg Subcutaneous Injection | Number of Participants With Vital Sign Abnormalities | 0 participants |
| Belatacept 125 mg Subcutaneous Injection | Number of Participants With Vital Sign Abnormalities | 0 participants |
| Belatacept 150 mg Subcutaneous Injections | Number of Participants With Vital Sign Abnormalities | 0 participants |
| Belatacept 200 mg Subcutaneous Injections | Number of Participants With Vital Sign Abnormalities | 0 participants |
| Belatacept 250 mg Subcutaneous Injections | Number of Participants With Vital Sign Abnormalities | 0 participants |
| Belatacept 125 mg Intravenous Infusion | Number of Participants With Vital Sign Abnormalities | 0 participants |
| Placebo | Number of Participants With Vital Sign Abnormalities | 0 participants |