Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03674125 | Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection | PHASE1 | COMPLETED | 32 | — | — | Sep 4, 2018 | May 4, 2020 | May 27, 2020 | 2 | South Korea |
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | GLS-6150 at 2.0 mg DNA/dose (3 dose prime plus boost) |
| Group 2 | EXPERIMENTAL | GLS-6150 at 1.0 mg DNA/dose (3 dose prime plus boost) |
| Group 3 | EXPERIMENTAL | GLS-6150 at 2.0 mg DNA/dose(3 dose prime plus boost) |
| Group 4 | EXPERIMENTAL | GLS-6150 at 2.0 mg DNA/dose(2 dose prime plus boost) |
| Name | Type | Description |
|---|---|---|
| GLS-6150 | BIOLOGICAL | Group 1: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, healthy volunteers); Group 2: GLS-6150 1.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 3: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 4: GLS-6150 2.0 mg at 0, 8, and 24 weeks (N=8, previously treated for HCV infection) |
Inclusion Criteria: 1. Age 19-65 years; 2. HCV seronegative (Group 1 only), HCV seropositive (Groups 2, 3, 4 only) 3. Prior treatment for genotype 1a or 1b Hepatitis C infection with treatment ending (12 weeks after end of DAA treatment, 24 weeks after end of combination treatment with Ribavirin/In...