Phase 1
Completed N=30
A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354
Asthma · Healthy
Source: ClinicalTrials.gov NCT00638989 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Absolute Bioavailability of CAT-354 After Subcutaneous Dose — 62.1; 60.1 percent bioavailability
Summary
To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Bioavailability of CAT-354 After Subcutaneous Dose |
62.1; 60.1 | — |
| SECONDARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
5; 5; 4; 0; 0; 0 | — |
| SECONDARY Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit |
0; 0; 0 | — |
| SECONDARY Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity]) |
903; 548; 1080 | — |
| SECONDARY Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56]) |
765; 467; 881 | — |
| SECONDARY Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose) |
6.02; 3.66; 3.59 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
58.3; 17.1; 36.6 | — |
| SECONDARY Dose Normalized Maximum Observed Concentration (Cmax/Dose) |
0.389; 0.114; 0.122 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) |
0.063; 5; 5 | — |
| SECONDARY Terminal Phase Elimination Half Life (t1/2) |
21.4; 19.2; 19.4 | — |
| SECONDARY Apparent Systemic Clearance (CL/F) After Subcutaneous Dose |
292; 307 | — |
| SECONDARY Apparent Systemic Clearance (CL/F) After Intravenous Dose |
188 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) After Intravenous Infusion |
4960 | — |
Eligibility Criteria
Inclusion Criteria
- Signed and dated written informed consent is obtained prior to any study related procedure taking place
- Males, aged 19-55 years
- No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
- A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
- Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
- A negative screen for drugs of abuse and alcohol
- Body mass index (BMI) between 18-30 kilogram per square meter (kg/m^2), inclusive
- No other clinically significant abnormality on history and clinical examination
- Able to comply with the requirements of the protocol.
Exclusion Criteria
- Any active concomitant disease including psychological disorders
- History of medication that might carry over effects into study
- Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354
- Participation in another investigational medicinal product study within 3 months of the start of this study or 5 half-lives of the previously administered investigational medicinal product (IMP), whichever is the longer except methodological studies in which no IMP was given
- Any acute illness in the 2 weeks before Day 0 (Visit 2)
- Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
- Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first degree relative of the aforementioned
- Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol
- The subject's primary care physician recommends the subject should not take part in the study
- Subjects with immunodeficiency disorders
- Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Data sourced from ClinicalTrials.gov (NCT00638989). 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.