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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03647228 | A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis | PHASE1 | COMPLETED | 98 | — | — | Dec 13, 2018 | Oct 13, 2020 | Feb 4, 2021 | 8 | Germany, United Kingdom |
| Arm | Type | Description |
|---|---|---|
| IONIS-ENaCRx | EXPERIMENTAL | Ascending single and multiple doses of IONIS-ENaCRx inhaled or nebulized. |
| Placebo | PLACEBO_COMPARATOR | Placebo comparator calculated volume to match active comparator inhaled or nebulized. |
| Name | Type | Description |
|---|---|---|
| IONIS-ENaCRx | DRUG | Ascending single and multiple doses of IONIS-ENaCRx inhaled or nebulized. |
| Placebo | DRUG | Placebo comparator calculated volume to match active comparator inhaled or nebulized. |
Inclusion Criteria (Healthy Volunteers) 1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. 2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non...