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NCT04920903
A Single and Multiple Ascending Dose Study of COR588
Phase 1 trial testing COR588 in Healthy Volunteers in 64 participants. Completed in 30 April 2022.
30 April 2022
Quick facts
| Lead sponsor | Cortexyme Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 26 August 2021 |
| Primary completion | 30 April 2022 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- COR588 — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Cortexyme Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety and tolerability of COR588 HCl in healthy male and female subjects.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alzheimer's disease drug development pipeline: 2022.
Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295 -
Establishment of a consensus protocol to explore the brain pathobiome in patients with mild cognitive impairment and Alzheimer's disease: Research outline and call for collaboration.
Lathe R, Schultek NM, Balin BJ, Ehrlich GD, et al · · 2023 · cited 28× · PMID 37283269 · DOI 10.1002/alz.13076 -
Gingipain inhibitors as an innovative therapy for periodontal and associated-systemic diseases: a systematic review.
Pedrosa ME, Martin V, Fernandes MH, Gomes PS. · · 2025 · cited 7× · PMID 40839040 · DOI 10.1007/s00784-025-06472-5 -
Unraveling brain aging through the lens of oral microbiota.
Hu Q, Wang S, Zhang W, Qu J, et al · · 2025 · cited 5× · PMID 38993126 · DOI 10.4103/nrr.nrr-d-23-01761
Verify or expand the search:
- PubMed search for NCT04920903
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Cortexyme Inc. trials
Trials by the same sponsor.
- NCT03823404 — GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease · Phase 2, PHASE3 · completed
- NCT03418688 — A Multiple Ascending Dose Study of COR388 · Phase 1 · completed
- NCT03331900 — Study of COR388 HCl 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 NCT04920903 (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 Cortexyme Inc.
- Last refreshed: 20 July 2022
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/NCT04920903.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing