Healthy VolunteersPhase 1NCT04868292
Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers
A Phase 1 study testing SPR206 in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SPR206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jun 2021to 29 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Subjects who have any of the following abnormalities on laboratory values at screening or Check-In including:
- White blood cell count < 3,000/mm3, hemoglobin < 11g/dL
- Absolute neutrophil count ≤ 2,000/mm3, platelet count <120,000/mm3
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Open-Label Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Intravenous Administration of SPR206 in Healthy Volunteers
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
- Being tested
- SPR206
- Keywords
- pharmacokinetics, alveolar macrophages (AM), epithelial lining fluid (ELF), intrapulmonary, bronchoalveolar lavage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPR206Drug
Three 100 mg SPR206 intravenous doses administered every 8 hours
| Study group | Role | What they receive |
|---|---|---|
| SPR206 | Experimental | Healthy subjects meeting eligibility criteria will receive a total of three 100 mg SPR206 intravenous doses administered every 8 hours. Receives: Drug: SPR206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma
Measured: 8 hours after the start of the third study drug IV infusion
Maximum observed concentration (Cmax) for ELF, AM, and plasma
Measured: 8 hours after the start of the third study drug IV infusion
Minimum concentration (Cmin) for ELF, AM, and plasma
Measured: 8 hours after the start of the third study drug IV infusion
Time to the maximum observed concentration (Tmax) for ELF, AM, and plasma
Measured: 8 hours after the start of the third study drug IV infusion
Secondary outcomes (9)
Incidence of Treatment-Emergent Adverse Events
To assess the incidents of treatment-emergent adverse events following three 100mg SPR206 intravenous doses administered every 8 hours. AEs will be classified by System Organ Class (SOC) and Preferred Term (PT). Incidence, frequency, severity and duration will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal vital sign assessments - blood pressure
To assess the incidents of abnormal systolic and diastolic blood pressure assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal vital sign assessments - body temperature
To assess the incidents of abnormal body temperature assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal vital sign assessments - heart rate
To assess the incidents of abnormal heart rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal vital sign assessments - respiratory rate
To assess the incidents of abnormal respiratory rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal physical exam assessments
To assess the incidents of abnormal body system assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Changes from baseline in physical examination findings will be classified as Normal, Abnormal NCS, and Abnormal CS. Frequency counts will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal ECG assessments - heart rate
To assess the incidents of abnormal heart rate assessment following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) for heart rate will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval
To assess the incidents of abnormal PR interval, RR interval, QRS interval, QT interval and QTcF interval assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) results will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.
Measured: Day -1 to Day 7
Incidence of abnormal safety laboratory assessments
To assess the incidents of abnormal hematology, serum chemistry, coagulation and urinalysis assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency counts of significant changes from baseline will be presented.
Measured: Day -1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start3 Jun 2021
- Primary completion16 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- David Melnick, MD, Study director, Spero Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868292
- Sponsor's protocol ID
- SPR206-102
- Other IDs
- CDMRP-JW180095-A, 2020-006019-52
- Status last verified
- Nov 2021
- First submitted
- 13 Apr 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Open-Label Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Intravenous Administration of SPR206 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04868292
- Acronym / sponsor ID
- SPR206-102
- Conditions
- Healthy Volunteers
- Keywords
- pharmacokinetics, alveolar macrophages (AM), epithelial lining fluid (ELF), intrapulmonary, bronchoalveolar lavage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Spero TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPR206 | Experimental | Drug: SPR206Healthy subjects meeting eligibility criteria will receive a total of three 100 mg SPR206 intravenous doses administered every 8 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPR206Three 100 mg SPR206 intravenous doses administered every 8 hours | Drug | SPR206 |
Primary outcome
Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
Maximum observed concentration (Cmax) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
Minimum concentration (Cmin) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
Time to the maximum observed concentration (Tmax) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
9 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - blood pressure
Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - body temperature
Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - heart rate
Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - respiratory rate
Time frame: Day -1 to Day 7
Incidence of abnormal physical exam assessments
Time frame: Day -1 to Day 7
Incidence of abnormal ECG assessments - heart rate
Time frame: Day -1 to Day 7
Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval
Time frame: Day -1 to Day 7
Incidence of abnormal safety laboratory assessments
Time frame: Day -1 to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Melnick, MD study director
Spero Therapeutics Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPR206 in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma (time frame: 8 hours after the start of the third study drug IV infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.