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NCT06625710
Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects
Phase 1 trial testing GV1001 in Neuro-Degenerative Disease in 59 participants. Completed in 25 August 2025.
25 August 2025
Quick facts
| Lead sponsor | GemVax & Kael |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 59 |
| Start date | 8 October 2024 |
| Primary completion | 25 August 2025 |
| Estimated completion | 25 August 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- GV1001
- Placebo
Conditions studied
- Neuro-Degenerative Disease — all drugs for Neuro-Degenerative Disease →
Sponsor
GemVax & Kael — full company profile →
Who can join
Adults 19 to 50, any sex, with Neuro-Degenerative Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to assess the the safety, tolerability and pharmacokinetic characteristics after single and multiple administration of GV1001 in healthy subjects. The main questions it aims to answer are: Safety and Tolerability of GV1001 in different dose scheme, and PK Characteristics of GV1001 in differenct dose scheme Part A: single dose, 8 days clinical trial participation including one 3-day hospitalization Part B \& Extra Cohort: Multiple dose, 42 days clinical trial participation (12 days treatment + 30 days safety follow-up) including two times of 3-day hospitalization.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06625710
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GV1001
Trials testing the same drug.
- NCT03959553 — GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD) · Phase 2 · withdrawn
Other recruiting trials for Neuro-Degenerative Disease
Currently open trials in the same condition.
- NCT07126821 — A Vision-Language Foundation Model for Brain Disease Diagnosis From Multimodal Data · recruiting
- NCT06151600 — A Prospective Natural History and Outcome Measure Discovery Study of Charcot-Marie-Tooth Disease, Type 4J · recruiting
- NCT05175417 — Visualization of Neural Targets With 3T MRI · recruiting
- NCT05655650 — Identifying Biomarkers in Alzheimer's Disease · recruiting
- NCT03233646 — Retinal Imaging in Neurodegenerative Disease · recruiting
Other GemVax & Kael trials
Trials by the same sponsor.
- NCT06235775 — Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011 · Phase 2 · completed
- NCT05819658 — GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP) · Phase 2 · completed
- NCT05189210 — GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) · Phase 2 · completed
- NCT04032067 — Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) · Phase 3 · completed
- NCT03959553 — GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD) · Phase 2 · withdrawn
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 NCT06625710 (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 GemVax & Kael
- Last refreshed: 19 November 2025
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/NCT06625710.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing