Phase 1
Completed N=140
A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes
Source: ClinicalTrials.gov NCT03714022 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Maximum Observed Serum Concentration (Cmax) — 237.0341; 236.2882 ug/mL
Summary
The main objective of this study is to compare the pharmacokinetics (PK) of the abatacept drug product converted from drug substance by a new drug substance process (Treatment A) relative to the current drug substance process (Treatment B) following a single dose (750 mg) intravenous (IV) infusion in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) |
237.0341; 236.2882 | — |
| PRIMARY Area Under the Curve AUC(INF) |
35693.8; 38254.6 | — |
| SECONDARY Time of Maximum Observed Serum Concentration (Tmax) |
1.000; 1.000 | — |
| SECONDARY Area Under the Curve AUC(0-T) |
34473.2; 36671.6 | — |
| SECONDARY Area Under the Curve AUC(0-28) |
28597.9; 29765.7 | — |
| SECONDARY Total Body Clearance (CLT) |
0.2642; 0.2445 | — |
| SECONDARY Volume of Distribution at Steady-State (Vss) |
0.10444; 0.10462 | — |
| SECONDARY Terminal Phase Elimination Half-life (T-HALF) |
357.464; 369.425 | — |
| SECONDARY Number of Participants Experiencing Positive Immunogenicity Response to Abatacept |
14; 11 | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
20; 18; 1; 2; 4; 3 | — |
| SECONDARY Change From Baseline in Blood Pressure |
-0.3; 2.0; -0.8; -0.7 | — |
| SECONDARY Change From Baseline in Heart Rate |
1.6; 0 | — |
| SECONDARY Change From Baseline in Respiration Rate |
1.0; 0.5 | — |
| SECONDARY Change From Baseline in Body Temperature |
-0.01; -0.06 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameters |
1.6; -1.8; 1.6; -0.0; -1.1; -2.1 | — |
| SECONDARY Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities |
0; 0 | — |
| SECONDARY Change From Baseline in Laboratory Test Results - Hematology 1 |
3.9; -1.6; -0.026; -0.015; -0.006; 0.012 | — |
| SECONDARY Change From Baseline in Laboratory Test Results - Hematology 2 |
-0.0034; -0.0023; -0.0008; 0.0024; 0.0107; 0.0019 | — |
| SECONDARY Change From Baseline in Laboratory Test Results - Hematology 3 |
-0.0017; 0.0014 | — |
| SECONDARY Change From Baseline in Laboratory Test Results - Chemistry 1 |
0.6; -1.3; -3.0; -0.4; 1.1; -1.1 | — |
| SECONDARY Change From Baseline in Laboratory Test Results - Chemistry 2 |
-0.01; -0.09; -0.25; -0.54; -2.2; -1.5 | — |
| SECONDARY Change From Baseline in Laboratory Test Results - Chemistry 3 |
0.29; 0.12; -0.027; -0.012; 0.4; -0.1 | — |
| SECONDARY Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 |
-0.6; 0.4; -0.9; -0.3; -1.2; -0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Body weight will be between 60 and 100 kg, inclusive.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study treatment.
- Women must not be breastfeeding.
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus 30 days (duration of ovulatory cycle) for a total of 115 days post-treatment completion.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus the duration of spermatogenesis (90 days) for a total of 175 days after the last dose of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time.
Exclusion Criteria
- Participants who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Participants who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
- Participants with a history of herpes zoster.
- Donation of blood to a blood bank or in a clinical study (except a screening visit or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks of study treatment administration for plasma only).
- Blood transfusion within 4 weeks of study treatment administration.
- Recent (within 6 months of study treatment administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges, or nicotine gum.
- History of allergy to abatacept or related compounds.
Data sourced from ClinicalTrials.gov (NCT03714022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.