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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07595458 | Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults | PHASE1 | NOT YET_RECRUITING | 48 | — | — | Jun 11, 2026 | Oct 4, 2027 | May 19, 2026 | 1 | United States |
Incidence of solicited local (injection site) and systemic AEs post-injection through Day 7 (with the inpatient and outpatient participant diaries being collected on Day 3 and Day 8, respectively)
Incidence of unsolicited AEs through end of study (EOS)
Incidence of Clinically Significant Changes in Vital Sign Measurements
| Arm | Type | Description |
|---|---|---|
| JST-018 Investigational Product | ACTIVE_COMPARATOR | - |
| JST-017 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JST-018 combination of 3 monoclonal antibodies | BIOLOGICAL | Monoclonal antibodies |
| Placebo | DRUG | Placebo Comparator |
Inclusion Criteria: 1. Healthy men or women 18 to 55 years of age 2. BMI between 18 and 32 kg/m2 3. Negative serum pregnancy test 4. Use of highly effective birth control method(s) for a minimum of 60 days prior to consent and is willing to continue use for at least 12 months, or abstinence 5. In g...