Acute, Post-operative PainPhase 1NCT04475198
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427
A Phase 1 study testing ST-2427 in people with Acute, Post-operative Pain, run by SiteOne Therapeutics, Inc. at 1 site in United States.
Trial summary
This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. Subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. A total of 30 subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute, Post-operative Pain
- What is being tested?
- ST-2427
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to 18 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Only subjects who meet the following criteria will be eligible for inclusion:
- Healthy adult males and/or females (of non-childbearing potential), 18 to 55 years of age (inclusive) at the time of screening;
- Body mass index (BMI) within 18.0 to 35.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening);
- Medically healthy without clinically significant abnormalities at the screening visit, including physical examination and vital signs within the following ranges: heart rate 50 to 100 bpm, systolic blood pressure 100 to 149 mmHg; diastolic 70 to 94 mmHg;
- The mean QTcF interval duration ≤450 msec for males and ≤470 msec for females measured from the triplicate ECGs taken at least 1 minute apart with QT wave corrected for heart rate (HR) using Fredericia's method
- Hemoglobin/hematocrit, white blood cell (WBC) count, and platelet count equal to or greater than the lower limit of normal range of the reference laboratory (may be confirmed upon repeat testing without Sponsor approval);
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- Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal to or less than the upper limit of normal for the reference laboratory (may be confirmed upon repeat testing); results of all other clinical chemistry and urine analytes without any clinically significant abnormality;
- Non-smokers (including tobacco, e-cigarettes or marijuana), and no use of any tobacco product for at least 1 month prior to admission in the study;
- Willing and able to provide written informed consent;
- Willing and able to comply with all study assessments and adhere to the protocol schedule;
- Have suitable venous access for blood sampling, as determined by an Investigator at screening;
- If female, be of non-childbearing potential (e.g. post-menopausal as demonstrated by follicle stimulating hormone (>40 mIU/mL), or surgically sterilized by tubal ligation or hysterectomy). Site personnel's review of the subject's medical records, medical examination, or medical history interview is acceptable evidence of female sterilization, verbal confirmation is adequate;
- If male, willing not to donate sperm from the time of first study drug administration until 90 days after the final administration of study drug. If male and not intending to engage in sexual intercourse over the duration of the study, willing to agree to abstinence at screening. If male and engaging in sexual intercourse, willing to use a double barrier method of contraception (condom and spermicide). The latter criterion applies to all males (and/or female partners) including males who are surgically sterile and must be followed from the time of first study drug administration until 90 days after the final administration of study drug.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- History or presence of significant cardiovascular (including arrhythmia and ventricular tachyphylaxis), pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by an Investigator to be clinically relevant;
- Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal to 1.5 x upper limit of normal for the reference laboratory (may be confirmed upon repeat testing);
- History of orthostatic reactions
- Orthostatic reaction at screening defined as drop in systolic blood pressure by ≥20 mmHg or drop in systolic blood pressure to <90 mmHg on standing for 3 minutes from the supine position.
- History of seizure disorders, except for non-complex febrile seizures in childhood with absence of non-febrile seizures in parents and siblings.;
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- Positive urine drug/alcohol testing at Screening or Day -2;
- Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb);
- Positive test results for COVID-19 (PCR or Antibodies)
- History of substance abuse or alcohol abuse (defined as greater than 2 standard drinks per day) within the previous 2 years;
- Use of any prescription medication or any over-the-counter medication, including herbal products and vitamins within 14 days or 5 half-lives (whichever is longer) prior to randomization;
- Documented hypersensitivity reaction or anaphylaxis to any medication;
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening, or receipt of a blood transfusion within 1 year of screening;
- Dosed in another investigational clinical trial within 30 days prior to Screening;
- Any condition or prior therapy, e.g. seizures, or head trauma, that may lead to CNS effects during the study;
- Documented or self-reported history of orthostatic hypotension or symptoms of hypotension such as dizziness, syncope or blurred vision upon standing;
- Any condition which is associated with increased brain permeability, e.g. cerebral ischemia, brain trauma, multiple sclerosis, brain tumors, brain infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427 IV Infusion in Healthy Subjects
This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. Subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design.
A total of 30 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study in healthy adult males and females of non-child-bearing potential to evaluate the safety, tolerability, and pharmacokinetics (PK) of ST-2427. This trial will include careful assessments of treatment effects on vital signs including cardiac and respiratory function and body temperature over a range of doses of ST-2427, administered as single doses. SiteOne Therapeutics, Inc. plans to use the safety, tolerability, and PK findings from this study to inform the doses and study design for Phase 2 clinical studies in subjects with acute post-operative pain.
Approximately 30 subjects, 6 subjects into each of 5 cohorts, will be enrolled in this study at a single clinical site.
Subjects will be randomized 4:2 to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. The Study will evaluate 5 dose strengths of ST-2427, one dose level in each of 5 cohorts of subjects.
- Conditions
- Acute, Post-operative Pain
- Being tested
- ST-2427, Placebo
- Keywords
- Pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-2427Drug
Investigational drug
PlaceboDrug
5% Dextrose Injection
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose: Cohort 1 | Experimental | 5 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (ST-2427 n=1, placebo n=1) before remainder of cohort. Receives: Drug: ST-2427; Drug: Placebo |
| Single Ascending Dose: Cohort 2 | Experimental | 10 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. Receives: Drug: ST-2427; Drug: Placebo |
| Single Ascending Dose: Cohort 3 | Experimental | 15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. Receives: Drug: ST-2427; Drug: Placebo |
| Single Ascending Dose: Cohort 4 | Experimental | 22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. Receives: Drug: ST-2427; Drug: Placebo |
| Single Ascending Dose: Cohort 5 | Experimental | 33 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. Receives: Drug: ST-2427; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
Measured: Day 1 through Day 8
Number of Participants With Adverse Events Assessed by Blood Pressure
Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).
Measured: Day 1 through Day 8
Number of Participants With Adverse Events Assessed by ECG
Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.
Measured: Day 1 through Day 8
Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments
Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.
Measured: Day 1 through Day 8
Number of Participants With Adverse Events Assessed by Body Weight
Body weight (kg) will be assessed for changes relative to baseline.
Measured: Day 1 through Day 8
Secondary outcomes (3)
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax
PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Measured: 0-48 hours
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Measured: 0-9 hours
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Measured: 0-25 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start4 Mar 2021
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Why it stopped: strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute, Post-operative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- SiteOne Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Markus Jerling, MD, PhD, Study director, Unaffliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475198
- Sponsor's protocol ID
- ST-2427-CS-001
- Other IDs
- 1UG3DA049599
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2020
- Last updated
- 3 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427 IV Infusion in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04475198
- Acronym / sponsor ID
- ST-2427-CS-001
- Conditions
- Acute, Post-operative Pain
- Keywords
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: strategic decision
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SiteOne Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Posted 3 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. Subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design.
A total of 30 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study in healthy adult males and females of non-child-bearing potential to evaluate the safety, tolerability, and pharmacokinetics (PK) of ST-2427. This trial will include careful assessments of treatment effects on vital signs including cardiac and respiratory function and body temperature over a range of doses of ST-2427, administered as single doses. SiteOne Therapeutics, Inc. plans to use the safety, tolerability, and PK findings from this study to inform the doses and study design for Phase 2 clinical studies in subjects with acute post-operative pain.
Approximately 30 subjects, 6 subjects into each of 5 cohorts, will be enrolled in this study at a single clinical site.
Subjects will be randomized 4:2 to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. The Study will evaluate 5 dose strengths of ST-2427, one dose level in each of 5 cohorts of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose: Cohort 1 | Experimental | Drug: ST-2427, Drug: Placebo5 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (ST-2427 n=1, placebo n=1) before remainder of cohort. |
| Single Ascending Dose: Cohort 2 | Experimental | Drug: ST-2427, Drug: Placebo10 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. |
| Single Ascending Dose: Cohort 3 | Experimental | Drug: ST-2427, Drug: Placebo15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. |
| Single Ascending Dose: Cohort 4 | Experimental | Drug: ST-2427, Drug: Placebo22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. |
| Single Ascending Dose: Cohort 5 | Experimental | Drug: ST-2427, Drug: Placebo33 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Only subjects who meet the following criteria will be eligible for inclusion:
Key exclusion criteria (17 listed)
- Subjects will be excluded from the study if they meet any of the following criteria:
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 |
|---|---|---|
| ST-2427Investigational drug | Drug | Single Ascending Dose: Cohort 1, Single Ascending Dose: Cohort 2, Single Ascending Dose: Cohort 3, Single Ascending Dose: Cohort 4, Single Ascending Dose: Cohort 5 |
| Placebo5% Dextrose Injection | Drug | Single Ascending Dose: Cohort 1, Single Ascending Dose: Cohort 2, Single Ascending Dose: Cohort 3, Single Ascending Dose: Cohort 4, Single Ascending Dose: Cohort 5 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 through Day 8
For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
Number of Participants With Adverse Events Assessed by Blood Pressure
Time frame: Day 1 through Day 8
Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).
Number of Participants With Adverse Events Assessed by ECG
Time frame: Day 1 through Day 8
Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.
Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments
Time frame: Day 1 through Day 8
Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.
Number of Participants With Adverse Events Assessed by Body Weight
Time frame: Day 1 through Day 8
Body weight (kg) will be assessed for changes relative to baseline.
3 secondary outcomes
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax
Time frame: 0-48 hours
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
Time frame: 0-9 hours
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
Time frame: 0-25 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Markus Jerling, MD, PhD study director
Unaffliated
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 ST-2427 in people with Acute, Post-operative Pain, run by SiteOne Therapeutics, Inc. at 1 site in United States.
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 13 inclusion and 17 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: stopped early, as of the sponsor's last update on 3 Aug 2023. 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 States. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-emergent Adverse Events (time frame: Day 1 through Day 8). The study lists 5 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 3 Aug 2023; AzTrials last refreshed its copy on 27 Oct 2026.