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NCT06294288
A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants
Phase 1 trial testing LP-003 Dose 1 (Single) in Chronic Spontaneous Urticaria in 60 participants. Completed in 4 March 2024.
4 March 2024
Quick facts
| Lead sponsor | Longbio Pharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 13 July 2022 |
| Primary completion | 4 March 2024 |
| Estimated completion | 4 March 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- LP-003 Dose 1 (Single) — full drug profile →
- LP-003 Dose 2 (Single)
- LP-003 Dose 3 (Single)
- LP-003 Dose 4 (Single)
- LP-003 Dose 5 (Single)
- Placebo (Single)
- LP-003 Dose 6 (Multiple) — full drug profile →
- LP-003 Dose 7 (Multiple)
- LP-003 Dose 8 (Multiple)
- Placebo (Multiple)
Conditions studied
- Chronic Spontaneous Urticaria — all drugs for Chronic Spontaneous Urticaria →
Sponsor
Longbio Pharma — full company profile →
Who can join
Adults 18 to 50, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD).
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 NCT06294288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LP-003 Dose 1 (Single)
Trials testing the same drug.
- NCT07148557 — A Study of Single Dose of LP-003 in Adolescent Subjects · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Chronic Spontaneous Urticaria
Currently open trials in the same condition.
- NCT07316114 — A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spont · recruiting
- NCT07358364 — Remibrutinib in Real-world Clinical Practice · recruiting
- NCT07358780 — Remibrutinib in Real-world Clinical Practice - a US Sub-study · recruiting
- NCT07408219 — A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients · recruiting
- NCT07219615 — A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. · Phase 2 · recruiting
Other Longbio Pharma trials
Trials by the same sponsor.
- NCT07363265 — Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease · Phase 2 · not yet recruiting
- NCT07313917 — A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyp · Phase 2 · not yet recruiting
- NCT07266155 — Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) · Phase 2 · not yet recruiting
- NCT07148557 — A Study of Single Dose of LP-003 in Adolescent Subjects · Phase 1, PHASE2 · active not recruiting
- NCT07342803 — Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients · Phase 2 · recruiting
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 NCT06294288 (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 Longbio Pharma
- Last refreshed: 12 December 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/NCT06294288.
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