Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPR206 · 3 trials · 2 indications
This outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatment
| Arm | Type | Description |
|---|---|---|
| SPR206 | EXPERIMENTAL | SPR206 100mg single-dose IV infused over 1 hour |
| Placebo | PLACEBO_COMPARATOR | The placebo used during this study is normal saline (0.9% sodium chloride for injection). SAD Cohorts: Subjects will receive single infusions of placebo (0.9% sodium chloride for injection) over one hour. MAD Cohorts: Subjects will receive q8h infusions of placebo over 1 hour for 7 consecutive days (Cohorts 9 - 12) and q8h infusions of placebo over 1 hour for 14 consecutive days (Cohort 13). |
| Name | Type | Description |
|---|---|---|
| SPR206 | DRUG | SPR206 100 mg single-dose IV infused over 1 hour |
| Placebo | DRUG | 0.9% sodium chloride for injection. SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo. |
Key Inclusion Criteria: * BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive) * Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees o...
SPR206 is an investigational small molecule being studied in healthy volunteers and in subjects with renal impairment. It is in Phase 1 clinical development, with completed trials assessing its safety, tolerability, and pharmacokinetics in these populations.
SPR206 is being developed by Spero Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SPRO.
SPR206 is in Phase 1 clinical development. All of its clinical trials are completed, and it remains an investigational drug that has not been approved by regulatory authorities.
SPR206 has completed three Phase 1 trials. NCT03792308 studied single and multiple doses in healthy volunteers in Australia. NCT04865393 evaluated pharmacokinetics and safety in subjects with various degrees of renal function in New Zealand. NCT04868292 assessed intrapulmonary pharmacokinetics in healthy volunteers in the United Kingdom.
Yes, SPR206 was studied in a completed Phase 1 trial, NCT04865393, which enrolled subjects with various degrees of renal function, including those with renal impairment. The trial was conducted in New Zealand and enrolled 37 participants.