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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03796910 | A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers | PHASE1 | COMPLETED | 96 | — | — | Dec 18, 2018 | Sep 24, 2019 | Oct 28, 2019 | 1 | United Kingdom |
Incidence and severity of AEs
| Arm | Type | Description |
|---|---|---|
| SPR720 for SAD | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive SPR720 |
| Placebo for SAD | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort will be randomized to receive placebo |
| SPR720 for MAD | EXPERIMENTAL | 6 out of 8 subjects per cohort will be randomized to receive SPR720 |
| Placebo for MAD | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort will be randomized to receive placebo |
| Name | Type | Description |
|---|---|---|
| SPR720 for SAD | DRUG | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered as a single dose. |
| Placebo for SAD | DRUG | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally as a single dose. |
| SPR720 for MAD | DRUG | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing. |
| Placebo for MAD | DRUG | Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing |
KEY INCLUSION CRITERIA: 1. Healthy adult male or female of non-childbearing potential,18 to 55 or ≥ 65 years of age (inclusive) at the time of screening; 2. Body mass index (BMI) ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). BMI = body weight (kg) / \[height (m)\]2 (subj...