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NCT01166555
Phase I Pharmacokinetics And Tolerability Of PF-04236921 Following Subcutaneous Administration To Healthy Volunteers
Phase 1 trial testing PF-04236921 in Healthy in 10 participants. Completed in 1 October 2010.
1 October 2010
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Enrollment | 10 |
| Start date | 1 May 2010 |
| Primary completion | 1 October 2010 |
| Estimated completion | 1 October 2010 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- PF-04236921 — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence and severity of adverse events
Time frame: 5 months -
Incidence and severity of clinical findings on physical examination
Time frame: 5 months -
Mean change from baseline in vital signs (blood pressure, pulse rate, oral or tympanic temperature) measurements
Time frame: 5 months -
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters: PRI, RR, QRS, QT, QTcF (Freidericia's correction) and HR (heart rate)
Time frame: 5 months -
Serum PF-04236921 concentrations will be determined by a validated assay and noncompartmental PK parameters
Time frame: 5 months
Sponsor's own description
This study will evaluate the safety, tolerability, and pharmacokinetics of PF-04236921 administered as a single subcutaneous dose in healthy volunteers.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).
Danese S, Vermeire S, Hellstern P, Panaccione R, et al · · 2019 · cited 137× · PMID 29247068 · DOI 10.1136/gutjnl-2017-314562 -
Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease.
Li C, Shoji S, Beebe J. · · 2018 · cited 9× · PMID 29776017 · DOI 10.1111/bcp.13641
Verify or expand the search:
- PubMed search for NCT01166555
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01166555 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 19 November 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01166555.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing