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NCT03577886
Safety and Tolerability of CDX-6114 in Healthy Volunteers
Phase 1 trial testing CDX-6114 in Healthy in 32 participants. Completed in 4 September 2018.
21 August 2018
Quick facts
| Lead sponsor | Codexis Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 4 July 2018 |
| Primary completion | 21 August 2018 |
| Estimated completion | 4 September 2018 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- CDX-6114
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Codexis Inc.
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Phenylketonuria.
van Spronsen FJ, Blau N, Harding C, Burlina A, et al · · 2021 · cited 330× · PMID 34017006 · DOI 10.1038/s41572-021-00267-0 -
A microparticulate based formulation to protect therapeutic enzymes from proteolytic digestion: phenylalanine ammonia lyase as case study.
Pereira de Sousa I, Gourmel C, Berkovska O, Burger M, et al · · 2020 · cited 14× · PMID 32107425 · DOI 10.1038/s41598-020-60463-y -
Clinical, genetic, and experimental research of hyperphenylalaninemia.
Chen A, Pan Y, Chen J. · · 2022 · cited 12× · PMID 36685931 · DOI 10.3389/fgene.2022.1051153
Verify or expand the search:
- PubMed search for NCT03577886
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CDX-6114
Trials testing the same drug.
- NCT03797664 — A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers · Phase 1 · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other Codexis Inc. trials
Trials by the same sponsor.
- NCT03797664 — A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers · 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 NCT03577886 (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 Codexis Inc.
- Last refreshed: 20 September 2018
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/NCT03577886.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing