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NCT05853835
First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641
Phase 1 trial testing LPX-TI641 in Autoimmune Diseases in 72 participants. Completed in 1 November 2024.
15 August 2024
Quick facts
| Lead sponsor | LAPIX Therapeutics Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 30 October 2023 |
| Primary completion | 15 August 2024 |
| Estimated completion | 1 November 2024 |
| Sites | 2 locations across Jordan, United States |
Drugs / interventions tested
- LPX-TI641 — full drug profile →
Conditions studied
- Autoimmune Diseases — all drugs for Autoimmune Diseases →
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
LAPIX Therapeutics Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Autoimmune Diseases or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy.
Cai L, Li Y, Tan J, Xu L, et al · · 2023 · cited 232× · PMID 37670328 · DOI 10.1186/s13045-023-01499-1
Verify or expand the search:
- PubMed search for NCT05853835
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LPX-TI641
Trials testing the same drug.
- NCT06982352 — Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis · Phase 1 · recruiting
- NCT06628206 — Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis · Phase 1 · recruiting
Other recruiting trials for Autoimmune Diseases
Currently open trials in the same condition.
- NCT06948110 — Deciphering the Genetic Architecture of Autoimmune Diseases · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07408336 — Clinical Study of AFN50 Injection in the Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07283315 — Exploratory Clinical Study of Second-generation CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in Treating Paedia · EARLY_PHASE1 · recruiting
- NCT07221890 — A Trial of Academic Detailing to Promote Prescribing of Biosimilars · NA · active not recruiting
Other LAPIX Therapeutics Inc. trials
Trials by the same sponsor.
- NCT06982352 — Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis · Phase 1 · recruiting
- NCT06628206 — Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis · Phase 1 · recruiting
- NCT05663853 — An Observational Biomarker Study in Multiple Sclerosis (MS) Patients · 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 NCT05853835 (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 LAPIX Therapeutics Inc.
- Last refreshed: 23 January 2025
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/NCT05853835.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing