Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers

NCT04868292 | Completed Phase 1

• 3 other identifiers: SPR206-102CDMRP-JW180095-A2020-006019-52
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma

  8 hours after the start of the third study drug IV infusion

• Maximum observed concentration (Cmax) for ELF, AM, and plasma

  8 hours after the start of the third study drug IV infusion

• Minimum concentration (Cmin) for ELF, AM, and plasma

  8 hours after the start of the third study drug IV infusion

• Time to the maximum observed concentration (Tmax) for ELF, AM, and plasma

  8 hours after the start of the third study drug IV infusion

Secondary Outcomes (9)

• Incidence of Treatment-Emergent Adverse Events

  Day -1 to Day 7

• Incidence of abnormal vital sign assessments - blood pressure

  Day -1 to Day 7

• Incidence of abnormal vital sign assessments - body temperature

  Day -1 to Day 7

• Incidence of abnormal vital sign assessments - heart rate

  Day -1 to Day 7

• Incidence of abnormal vital sign assessments - respiratory rate

  Day -1 to Day 7

Study Arms (1)

SPR206

EXPERIMENTAL

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

Drug: SPR206

Interventions

SPR206 DRUG

Three 100 mg SPR206 intravenous doses administered every 8 hours

SPR206

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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):
• Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)
• Difficulty breathing
• Cough
• Sore throat
• New or recent loss of taste or smell
• 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

Sponsors & Collaborators

• Spero Therapeutics: lead
• United States Department of Defense: collaborator

Study Sites (1)

Medical Facility

Manchester, M23 9QZ, United Kingdom

Location

Study Officials

• David Melnick, MD

  Spero Therapeutics Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 30, 2021
• Study Start: June 3, 2021
• Primary Completion: September 16, 2021
• Study Completion: September 29, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)