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NCT02711423
A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
Phase 1 trial testing Gantenerumab in Healthy Volunteer in 18 participants. Completed in 28 September 2016.
28 September 2016
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 31 March 2016 |
| Primary completion | 28 September 2016 |
| Estimated completion | 28 September 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gantenerumab — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 18 to 45, male only, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease.
Cummings J, Osse AML, Cammann D, Powell J, et al · · 2024 · cited 228× · PMID 37955845 · DOI 10.1007/s40259-023-00633-2 -
Efficacy and safety of anti-amyloid-<i>β</i> immunotherapy for Alzheimer's disease: a systematic review and network meta-analysis.
Mo JJ, Li JY, Yang Z, Liu Z, et al · · 2017 · cited 65× · PMID 29296624 · DOI 10.1002/acn3.469 -
Amyloid-β and α-Synuclein Immunotherapy: From Experimental Studies to Clinical Trials.
Nimmo JT, Kelly L, Verma A, Carare RO, et al · · 2021 · cited 31× · PMID 34539340 · DOI 10.3389/fnins.2021.733857 -
Recent Trends in Active and Passive Immunotherapies of Alzheimer's Disease.
Alshamrani M. · · 2023 · cited 6× · PMID 37366656 · DOI 10.3390/antib12020041
Verify or expand the search:
- PubMed search for NCT02711423
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gantenerumab
Trials testing the same drug.
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- NCT04374253 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With · Phase 3 · terminated
- NCT04592341 — A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With · Phase 2 · terminated
- NCT06424236 — Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia: A Study of Potential Disease Modifying · Phase 2, PHASE3 · terminated
- NCT04339413 — A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheim · Phase 3 · terminated
Other recruiting trials for Healthy Volunteer
Currently open trials in the same condition.
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- NCT07439263 — Single Ascending Dose Study of HB2198 in Healthy Participants · Phase 1 · recruiting
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Other Hoffmann-La Roche trials
Trials by the same sponsor.
- NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
- NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
- NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · 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 NCT02711423 (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 Hoffmann-La Roche
- Last refreshed: 10 April 2019
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/NCT02711423.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing