Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers

NCT ID: NCT04868292

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2021-09-29

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

pharmacokinetics; alveolar macrophages (AM); epithelial lining fluid (ELF); intrapulmonary; bronchoalveolar lavage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SPR206

Healthy subjects meeting eligibility criteria will receive a total of three 100 mg SPR206 intravenous doses administered every 8 hours.

Group Type: EXPERIMENTAL

SPR206

Intervention Type: DRUG

Three 100 mg SPR206 intravenous doses administered every 8 hours

Interventions

SPR206

Three 100 mg SPR206 intravenous doses administered every 8 hours

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Melnick, MD

Role: STUDY_DIRECTOR

Spero Therapeutics Inc

Locations

Medical Facility

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

CDMRP-JW180095-A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2020-006019-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPR206-102

Identifier Type: -

Identifier Source: org_study_id