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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06943378 | Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults | PHASE1 | ACTIVE NOT_RECRUITING | 104 | — | — | May 16, 2025 | Oct 1, 2027 | May 12, 2026 | 1 | United States |
1. 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). 2. Incidence of unsolicited AEs through end of study (EOS). 3. Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs) post-injection through EOS.
| Arm | Type | Description |
|---|---|---|
| JST-010: The active investigational product | ACTIVE_COMPARATOR | - |
| JST-012 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Monoclonal antibody JST-010 | BIOLOGICAL | Active study drug |
| Placebo | DRUG | Placebo |
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...