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NCT01815827
An Open-label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
Phase 1 trial testing inclacumab in Healthy Volunteer in 62 participants. Completed in 1 February 2014.
1 February 2014
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Enrollment | 62 |
| Start date | 1 June 2013 |
| Primary completion | 1 February 2014 |
| Estimated completion | 1 February 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- inclacumab — full drug profile →
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteer. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: up to 197 days -
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: up to 197 days
Sponsor's own description
This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01815827
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hoffmann-La Roche trials
Trials by the same sponsor.
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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 NCT01815827 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 1 November 2016
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/NCT01815827.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing