Last reviewed · How we verify
NCT06291948
A Clinical Study With Adalimumab Biosimilar
Phase 1 trial testing Humira® (adalimumab) AC Pen [Reference Product] in Pharmacokinetics in 150 participants. Completed in 20 October 2023.
10 January 2023
Quick facts
| Lead sponsor | Laboratorios Richmond S.A.C.I.F. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 150 |
| Start date | 1 August 2022 |
| Primary completion | 10 January 2023 |
| Estimated completion | 20 October 2023 |
| Sites | 1 location across Argentina |
Drugs / interventions tested
- Humira® (adalimumab) AC Pen [Reference Product] — full drug profile →
- Adalimumab Richmond [Test Product] — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
- Safety Issues — all drugs for Safety Issues →
Sponsor
Laboratorios Richmond S.A.C.I.F. — full company profile →
Who can join
Adults 21 to 55, any sex, with Pharmacokinetics or Safety Issues. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) \[Test Product\] vs. Humira® AC Pen \[Reference Product\]
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 NCT06291948
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pharmacokinetics
Currently open trials in the same condition.
- NCT07583407 — Pharmacokinetics of Kava and Kratom Alone and in Combination · NA · recruiting
- NCT07422285 — Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Do · Phase 1 · recruiting
- NCT07060209 — Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults · Phase 1 · recruiting
- NCT06859723 — High Potency Cannabis: Acute and Protracted Effects · Phase 1 · recruiting
- NCT06733675 — Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination · Phase 1 · recruiting
Other Laboratorios Richmond S.A.C.I.F. trials
Trials by the same sponsor.
- NCT07448506 — PHASE III, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF NIFEDIPINE 30M · Phase 3 · completed
- NCT03919448 — A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab · Phase 1 · completed
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 NCT06291948 (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 Laboratorios Richmond S.A.C.I.F.
- Last refreshed: 4 March 2024
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/NCT06291948.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing