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Also known as SPR720 Oral Capsule
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 a small molecule drug candidate developed by Spero Therapeutics, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United Kingdom. The trial evaluated its safety, tolerability, and pharmacokinetics. SPR720 is an investigational agent and has not been approved by the FDA.
SPR720 is being developed by Spero Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol SPRO. The company sponsored the Phase 1 study of SPR720 conducted in the United Kingdom. Spero Therapeutics is a clinical-stage biopharmaceutical company.
SPR720 is in Phase 1 clinical development. A single Phase 1 trial, NCT03796910, has been completed. That study enrolled 96 healthy adult volunteers and assessed the safety, tolerability, and pharmacokinetics of SPR720. SPR720 remains an investigational drug and is not FDA approved.
SPR720 has been studied in one clinical trial, NCT03796910, titled "A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers." The Phase 1 trial was completed, enrolled 96 participants, and was conducted in the United Kingdom. It was randomized, double-blind, and placebo-controlled.
The Phase 1 trial of SPR720, NCT03796910, was a randomized, double-blind, placebo-controlled study. It enrolled 96 healthy volunteers aged 18 years and older of all sexes in the United Kingdom. The trial evaluated safety, tolerability, and pharmacokinetics and has been completed.