eligibility_summary
Inclusion: Healthy adults 19–50 (Part B: males only, extra cohort: Caucasian), 50–90 kg, BMI 18–27, intact skin at application site, no conditions affecting PK. Exclusion: significant disease, hypersensitivity, positive HBV/HCV/HIV/syphilis, (Part B) abnormal testosterone/LH/FSH, substance abuse/positive drug test, recent meds/barbiturates/trial/blood donation/transfusion, high alcohol or cannot abstain alcohol/caffeine/grapefruit/smoking, no contraception, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: GV1001 (tertumotide), a lyophilized peptide derived from human telomerase reverse transcriptase (hTERT), drug type: peptide immunotherapy/therapeutic vaccine, given subcutaneously. Comparator: placebo (0.9% saline). Mechanism of action: GV1001 provides an hTERT peptide epitope that is processed by antigen‑presenting cells and displayed via MHC to activate hTERT‑specific CD4+/CD8+ T‑cell responses, enabling immune recognition of telomerase-expressing cells. Cells/pathways targeted: the telomerase (hTERT) pathway, antigen-presenting cells and adaptive T‑cell immunity, target cell population includes hTERT‑expressing (highly proliferative/tumor) cells. This Phase 1 SAD/MAD trial in healthy adults evaluates safety, tolerability, and pharmacokinetics.