Drugs / HLX6018
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06310746 | Apr 2024 → Jul 2025 | idiopathic pulmonary fibrosis | Shanghai Henlius Biotech | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-03-12 | Shanghai Henlius Biotech | Regulatory The IND Application of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018 Approved by NMPA henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for clinical trial of HLX6018,a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-04-23 | Shanghai Henlius Biotech | First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018 henlius.com ↗ |
| 2024-03-12 | Shanghai Henlius Biotech | The IND Application of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018 Approved by NMPA henlius.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX6018 | “A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects” NCT06310746 ↗ |
| Modality | Monoclonal antibody | “GARP/TGF-β1 monoclonal antibody” NCT06310746 ↗ |
| Route | Intravenous | “single intravenous administration of HLX6018” NCT06310746 ↗ |