Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers

Spero Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: SPR206

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT04868292

SPR206-102

CDMRP-JW180095-A (Other Grant/Funding Number)

2020-006019-52 (EudraCT Number)

Details and patient eligibility

About

To evaluate the intrapulmonary pharmacokinetics (PK), including epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations, of SPR206 as well as plasma concentrations of SPR206 in healthy adult volunteers.

Enrollment

34 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Non-smoker for at least 12 months prior to screening for the study
BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)
Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry, coagulation, and urinalysis
Forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value at screening
Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food from 48 hours prior to study drug administration until discharge from the clinical unit
If male, must agree to use a condom and have a non-pregnant female partner of childbearing potential agree to use a highly effective method of contraception
If female, must be of non-childbearing potential or, if female of childbearing potential, a willingness to abstain from sexual activity or agree to use a high effective method of contraception that could lead to pregnancy
Other inclusion criteria per protocol

Exclusion criteria

History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant
Recent history (within 6 months) of known or suspected Clostridium difficile infection
History of seizure disorders
Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV Ab)
Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or prior to first dosing
Presence of the following symptoms at screening or within 28 days prior to screening or check-in (Day -1):
1. Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)
2. Difficulty breathing
3. Cough
4. Sore throat
5. New or recent loss of taste or smell
6. Nausea, vomiting or diarrhea
Close contact with anyone who tested positive for SARS-CoV-2 infection within 28 days prior to screening or check-in (Day -1)
Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females
Subjects who have any of the following abnormalities on laboratory values at screening or Check-In including:
1. White blood cell count < 3,000/mm3, hemoglobin < 11g/dL
2. Absolute neutrophil count ≤ 2,000/mm3, platelet count <120,000/mm3
3. alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) greater than the upper limit of normal (ULN) for the reference laboratory
History of substance abuse or alcohol abuse
Use of prescription medicine & tobacco/nicotine or marijuana-containing products
A female who is pregnant or breastfeeding
Other exclusion criteria per protocol