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Spero Therapeutics Inc (SPRO)
NASDAQ:SPRO
Tbp-Pi-Hbr
Healthy Participants
Phase I
Completed
A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants
Dec 06, 2024
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Imipenem-Cilastatin, Dummy Infusion, Dummy Tablets, Tbp-Pi-Hbr
Urinary Tract Infection, Acute Pyelonephritis
Phase III
Completed
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Sep 22, 2023
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Azithromycin, Spr720, Ethambutol
Healthy Volunteers
Phase I
Completed
A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants
Jul 20, 2023
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Spr720
Healthy Volunteer
Phase I
Completed
A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers.
Jul 13, 2023
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Tbp-Pi-Hbr
Healthy Volunteers
Phase I
Completed
A Study to Compare Two Bioanalytical Assays for Tebipenem
May 03, 2023
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Spr720 500 Mg, Spr720 1000 Mg
Nontuberculous Mycobacterial Pulmonary Disease (Ntm-Pd)
Phase II
Completed
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
Aug 09, 2022
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Spr206
Renal Impairment
Phase I
Completed
Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function
Apr 26, 2021
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Spr206
Healthy Volunteers
Phase I
Completed
Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers
Apr 13, 2021
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Tbpm-Pi-Hbr
Healthy Volunteers
Phase I
Completed
Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
Jan 04, 2021
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Tbpm-Pi-Hbr
Healthy Volunteers
Phase I
Completed
Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects
Sep 17, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Spero Therapeutics Inc (SPRO) have in its pipeline
SPRO is currently developing the following drugs: Tbp-Pi-Hbr, Imipenem-Cilastatin, Dummy Infusion, Dummy Tablets, Tbp-Pi-Hbr, Azithromycin, Spr720, Ethambutol. These drug candidates are in various stages of clinical development as the company works toward FDA approval.