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NCT03762031
A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
Phase 1 trial testing GC4711 30mg in Healthy in 70 participants. Completed in 4 March 2020.
4 March 2020
Quick facts
| Lead sponsor | Galera Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 19 March 2019 |
| Primary completion | 4 March 2020 |
| Estimated completion | 4 March 2020 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- GC4711 30mg — full drug profile →
- GC4711 60mg — full drug profile →
- GC4711 90mg — full drug profile →
- GC4711 120mg — full drug profile →
- Placebo
- GC4711 75mg
- GC4711 105mg — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Galera Therapeutics, Inc. — full company profile →
Who can join
Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Superoxide Dismutase 1 in Health and Disease: How a Frontline Antioxidant Becomes Neurotoxic.
Trist BG, Hilton JB, Hare DJ, Crouch PJ, et al · · 2021 · cited 148× · PMID 32144830 · DOI 10.1002/anie.202000451 -
Mitochondrial Oxidative Stress and Cell Death in Podocytopathies.
Zhu YT, Wan C, Lin JH, Hammes HP, et al · · 2022 · cited 31× · PMID 35327595 · DOI 10.3390/biom12030403
Verify or expand the search:
- PubMed search for NCT03762031
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Galera Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT04698915 — Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer · Phase 2 · terminated
- NCT04476797 — Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC · Phase 1, PHASE2 · terminated
- NCT04555096 — A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 · Phase 2 · terminated
- NCT04529850 — Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer · Phase 2 · completed
- NCT04225026 — Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer · Phase 2 · terminated
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 NCT03762031 (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 Galera Therapeutics, Inc.
- Last refreshed: 14 August 2020
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/NCT03762031.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing