Phase 1
Completed N=312
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT03970824 ↗
Enrolled (actual)
312
Serious AEs
1.0%
Results posted
Dec 2020
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) — 2656.5; 2469.7; 2690.6 h•μg/mL
Summary
This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) |
2656.5; 2469.7; 2690.6 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) |
2372.7; 2185.0; 2394.7 | — |
| PRIMARY Maximum Serum Concentration (Cmax) |
3.619; 3.556; 3.660 | — |
| SECONDARY Time to the Maximum Serum Concentration (Tmax) |
167.433; 166.833; 144.000 | — |
| SECONDARY Terminal Elimination Half-life (t1/2) |
340.3; 331.3; 339.5 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects
- BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth
Exclusion Criteria
- A medical history and/or condition that is considered significant
- Clinically significant allergic reactions, hypersensitivity
- History or current infection of hepatitis B virus (except for past resolved infection), hepatitis C virus, human immunodeficiency virus, or syphilis
- Active or latent Tuberculosis
- History of malignancy
- Previous monoclonal antibody or fusion protein treatment, or current use of any biologic
- Planning to be pregnant or father a child or donate sperm within 5 month after administration
- Undergone treatment with an investigational drug or participated in another clinical trial within 90 days or 5 half-lives (whichever is longer)
Data sourced from ClinicalTrials.gov (NCT03970824). 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.