Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPR720 for SAD · 1 trial · 1 indication
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...
SPR720 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety, tolerability, and pharmacokinetics. The drug is not approved for any indication and remains under investigation.
SPR720 is being developed by Spero Therapeutics, Inc., a biopharmaceutical company traded under the ticker SPRO. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy volunteers.
SPR720 is in Phase 1 clinical development. A Phase 1 study has been completed, which enrolled 96 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any use.
SPR720 has one completed clinical trial, NCT03796910, titled 'A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers.' This Phase 1 study was conducted in the United Kingdom and enrolled 96 healthy adult participants.
SPR720 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety, tolerability, and pharmacokinetics in healthy volunteers, and the drug has not yet received regulatory approval.