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NCT06597422
A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects
Phase 1 trial testing STSP-0902 ophthalmic solution in Neurotrophic Keratitis in 82 participants. Completed in 23 January 2025.
23 January 2025
Quick facts
| Lead sponsor | Staidson (Beijing) Biopharmaceuticals Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 20 October 2024 |
| Primary completion | 23 January 2025 |
| Estimated completion | 23 January 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- STSP-0902 ophthalmic solution — full drug profile →
- STSP-0902 Placebo
- STSP-0902 ophthalmic solution — full drug profile →
- STSP-0902 ophthalmic solution — full drug profile →
- STSP-0902 Placebo
- STSP-0902 ophthalmic solution — full drug profile →
Conditions studied
- Neurotrophic Keratitis — all drugs for Neurotrophic Keratitis →
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd — full company profile →
Who can join
Adults 18 to 45, any sex, with Neurotrophic Keratitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of STSP-0902 ophthalmic solution in healthy subjects following single and multiple administrations. The study plans to enroll 80 healthy subjects and is divided into three stages: the single-dose study stage, the multiple-dose study stage, and the tear PK study stage. The single-dose and multiple-dose study stages are randomized, double-blind, placebo-controlled, dose-escalation designs, while the tear PK study stage is a single-dose, open-label design.
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 NCT06597422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neurotrophic Keratitis
Currently open trials in the same condition.
- NCT06964269 — Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune D · Phase 4 · recruiting
- NCT05927428 — Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis · Phase 2 · recruiting
- NCT06947850 — DOMPE -MT Neurotrophic Keratitis · Phase 4 · active not recruiting
- NCT04573647 — OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate · recruiting
Other Staidson (Beijing) Biopharmaceuticals Co., Ltd trials
Trials by the same sponsor.
- NCT07168161 — BDB-001 Phase III Trial in ANCA-Associated Vasculitis · Phase 3 · recruiting
- NCT06563713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STSP-0902 in Healthy Subjects · Phase 1 · completed
- NCT06289166 — Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor · Phase 2 · completed
- NCT06038916 — To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome · Phase 1, PHASE2 · completed
- NCT06148389 — The Safety and Tolerability of STSA-1301 Subcutaneous Injection in Healthy Subjects · 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 NCT06597422 (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 Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Last refreshed: 13 April 2026
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/NCT06597422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing