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NCT05912049
A Phase 1, Randomized, Double-blind，Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Participants
Phase 1 trial testing 9MW3811 Injection in Idiopathic Pulmonary Fibrosis in 24 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 26 July 2023 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- 9MW3811 Injection — full drug profile →
- Placebo
Conditions studied
- Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Idiopathic Pulmonary Fibrosis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
Time frame: up to Day113
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Sponsor's own description
This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05912049
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · recruiting
- NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting
Other Mabwell (Shanghai) Bioscience Co., Ltd. trials
Trials by the same sponsor.
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07314723 — 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer · Phase 2 · recruiting
- NCT06926998 — 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors · Phase 1, PHASE2 · not yet recruiting
- NCT06804590 — A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis · Phase 3 · recruiting
- NCT06692166 — A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Ca · Phase 3 · 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 NCT05912049 (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 Mabwell (Shanghai) Bioscience Co., Ltd.
- Last refreshed: 29 August 2023
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/NCT05912049.
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