Healthy SubjectsPhase 1NCT05309915
A Study of STP707 Administered by IV in Healthy Subjects
A Phase 1 study testing STP707 in people with Healthy Subjects, run by Sirnaomics at 1 site in United States.
Trial summary
Single center study, randomized, to evaluate safety, tolerability, PK of single ascending dose of STP707 when administered by IV infusion in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- STP707
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 30 Aug 2022
- 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
- Male or female subjects 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF).
- Subjects must be in generally reasonable health with clinically insignificant screening and admission results (medical history, 12-lead electrocardiogram [ECG], physical examination, and laboratory tests), as determined by the Investigator.
- Subjects must have a body mass index (BMI) >18 kg/m2 or <32 kg/m2
- Subjects must have aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBIL), alkaline phosphatase (ALP), and glucose within upper limit of normal (ULN) range per reference laboratory reference ranges at Screening and Day -1 (Admission); one repeat laboratory analysis allowed per Investigator discretion.
- Women of childbearing potential must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 (Admission), must not be actively breastfeeding, or planning to become pregnant during the study, and if not practicing abstinence from heterosexual activity that could result in conception (if this is the preferred and usual lifestyle of the subject), must agree to use 2 approved methods of birth control, during the study and for at least 60 days after the last dose of study drug, from the list below:
- Condom plus diaphragm.
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- Condom plus cervical cap or female condom.
- Hormonal contraceptives (stable dose for 28 days [4 weeks] prior to Screening) plus condom.
- Intrauterine device (in place for 28 days [4 weeks] prior to Screening) plus condom.
- Condom plus spermicide.
- Partner vasectomy and use of barrier contraception methods (e.g., male condom, diaphragm, or sponge with spermicide).
- Women of nonchildbearing potential must be either surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/salpingectomy) or >1 year postmenopausal with follicle-stimulating hormone (FSH) in the postmenopausal range and not actively breastfeeding.
- Men must agree to use barrier contraception (condom with spermicide) and refrain from sperm donation from the first dose of study drug until at least 90 days after the last dose of study drug. Post vasectomy, men must agree to use a barrier method (or partner barrier method) from the first dose of study drug until at least 90 days after the last dose of study drug.
- Subjects must be informed of the nature of the study and must have agreed to and be able to read, review, and sign the study ICF prior to any study related procedure being performed.
Who cannot join
- Current or previous cancer, excluding basal cell carcinoma that has been in remission for >5 years prior to dosing and in situ cervical carcinoma; diabetes or known diagnosis of prediabetes; or any clinically significant cardiovascular (including ECG disturbances or history of rhythm disturbance/abnormality), endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder.
- Hypertension, defined as blood pressure >140/90 mmHg (2 separate readings at least 15 minutes apart if first reading is not within normal range).
- NOTE: For the Screening blood pressure measurement, subjects should avoid smoking, caffeine, or exercise within 30 minutes prior to measurement; empty his or her bladder; then sit quietly in a comfortable chair with back support for at least 5 minutes prior to blood pressure measurement; and remain still during the measurement. Blood pressure should be measured with the subject's limb supported, with the blood pressure cuff at heart level, and with the correct cuff size. The measurement should not be taken over clothes.
- Hyperlipidemia defined as
- Cholesterol >300 mg/dL.
- Low-density lipoprotein cholesterol >190 mg/dL.
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- And/or triglycerides >500 mg/dL. Note: Abnormal laboratory values may be repeated once at Investigator discretion.
- Hemoglobin A1c (HbA1c) >6.5% at Screening. Note: Abnormal laboratory values may be repeated once at Investigator discretion.
- Hemoglobin or hematocrit outside upper and lower limits of normal range per reference laboratory range at both Screening and Day -1 (Admission).
- Creatinine kinase (CK) > ULN at Screening and Day-1 (Admission).
- Serum creatinine above upper limit of normal range per reference laboratory reference ranges at both Screening and Day -1 (Admission). Note: Abnormal laboratory values may be repeated once at Investigator discretion.
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration equation) at Screening and Day-1 (Admission). One retest of the exclusionary eGFR value is allowed at the discretion of the Investigator.
- Known sensitivity or allergies to Trehalose; history of severe hypersensitivity to IV infusion.
- Unwillingness to abstain from alcohol for 72 hours prior to dosing through EOS/ET.
- Use of prescription or nonprescription drugs (excluding hormonal contraceptives), if clinically applicable, including vitamins, supplements, herbal preparations, and medicines that prolong QT/QTc within 7 days or 5 times longer than the half-life (whichever is longer) prior to the first dose of study drug through EOS (approximately 60 days).
- Blood or plasma donation within 60 days prior to dosing.
- Use of live and non-live vaccine within 30 days prior to the first dose of study drug or an intention to receive such a vaccine at any time during the study.
- Received an investigational agent in another clinical study within 30 days prior to the first dose of study drug, or within 10 times longer than the half-life of the compound with which the subject was treated, whichever is longer.
- Positive results of any of the virology tests (human immunodeficiency virus (HIV test), hepatitis B virus (HBsAg test) or hepatitis C virus (hepatitis C antibody test).
- Diagnosed to be COVID-19 positive by polymerase chain reaction testing (SARS CoV 2 RT PCR positive) of a respiratory specimen (preferably a nasopharyngeal swab) on Day -2.
- NOTE: Rapid Antigen Test may be used if PCR testing is unavailable
- Personal or family history of vascular aneurysms and disorders.
- Personal or family history of long QT syndrome.
- Personal or family history of hypokalemia.
- Corrected QT interval using Fridericia's formula (> 450 msec) based on the average of triplicate ECGs.
- History of alcoholism or abuse within 2 years prior to Screening.
- Positive urine drug or breath alcohol screen at Screening or Day -1 (Admission).
- Any condition that, in the opinion of the Investigator, would complicate or compromise the study data or the well-being of the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Randomized, Dose-Escalation, Sequential Cohort Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of STP707 Administered Intravenously in Healthy Subjects
Single center study, randomized, to evaluate safety, tolerability, PK of single ascending dose of STP707 when administered by IV infusion in healthy subjects.
Read the detailed description
The study includes a screening period, admission, treatment period and follow up period.
Four doses will be evaluated in 4 cohorts with up to 10 subjects per cohort. Each individual will receive a single dose of STP707 or placebo.
- Conditions
- Healthy Subjects
- Being tested
- STP707
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP707Drug
STP707 Powder for Injection, contains 2 (siRNA) and (HKP+H) delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Dose 3mg of STP707 (8 subjects) + placebo (2 subjects) randomized Receives: Drug: STP707 |
| Cohort 2 | Other | Dose 6mg of STP707 (8 subjects) + placebo (2 subjects) randomized Receives: Drug: STP707 |
| Cohort 3 | Other | Dose 12mg of STP707 (8 subjects) + placebo (2 subjects) randomized Receives: Drug: STP707 |
| Cohort 4 | Other | Dose 24mg of STP707 (8 subjects) + placebo (2 subjects) randomized Receives: Drug: STP707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety & tolerability of STP707 when administered by IV in healthy subjects
Number and percentage of subjects in total experiencing treatment-emergent (AEs) from baseline.
Measured: 60 DAys
Evaluate safety & tolerability of STP707 when administered by IV in healthy subjects
Number and percentage of subjects in each dose cohort experiencing treatment-emergent (AEs) from baseline.
Measured: 60 days
Secondary outcomes (1)
Evaluate (PK) of STP707 when administered by IV in healthy subjects
PK parameters will be computed from individual plasma concentrations of STP707. Plasma concentrations will be assessed at each time point by study visit and cohort.
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start28 Feb 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Sequential
- Model description
- Initially, for each cohort subjects will be randomized 1:1 to STP707 or placebo. After safety evaluation up to 8 additional subjects will be enrolled randomized 7:1 to STP707 or placebo within the same cohort.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Francois Lebel, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309915
- Sponsor's protocol ID
- SRN-707-002
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Dose-Escalation, Sequential Cohort Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of STP707 Administered Intravenously in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05309915
- Acronym / sponsor ID
- SRN-707-002
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 4 Apr 2022 (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.
Single center study, randomized, to evaluate safety, tolerability, PK of single ascending dose of STP707 when administered by IV infusion in healthy subjects.
Detailed description
The study includes a screening period, admission, treatment period and follow up period.
Four doses will be evaluated in 4 cohorts with up to 10 subjects per cohort. Each individual will receive a single dose of STP707 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Initially, for each cohort subjects will be randomized 1:1 to STP707 or placebo. After safety evaluation up to 8 additional subjects will be enrolled randomized 7:1 to STP707 or placebo within the same cohort.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: STP707Dose 3mg of STP707 (8 subjects) + placebo (2 subjects) randomized |
| Cohort 2 | Other | Drug: STP707Dose 6mg of STP707 (8 subjects) + placebo (2 subjects) randomized |
| Cohort 3 | Other | Drug: STP707Dose 12mg of STP707 (8 subjects) + placebo (2 subjects) randomized |
| Cohort 4 | Other | Drug: STP707Dose 24mg of STP707 (8 subjects) + placebo (2 subjects) randomized |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female subjects 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF).
- Subjects must be in generally reasonable health with clinically insignificant screening and admission results (medical history, 12-lead electrocardiogram [ECG], physical examination, and laboratory tests), as determined by the Investigator.
- Subjects must have a body mass index (BMI) >18 kg/m2 or <32 kg/m2
- Subjects must have aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBIL), alkaline phosphatase (ALP), and glucose within upper limit of normal (ULN) range per reference laboratory reference ranges at Screening and Day -1 (Admission); one repeat laboratory analysis allowed per Investigator discretion.
- Women of childbearing potential must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 (Admission), must not be actively breastfeeding, or planning to become pregnant during the study, and if not practicing abstinence from heterosexual activity that could result in conception (if this is the preferred and usual lifestyle of the subject), must agree to use 2 approved methods of birth control, during the study and for at least 60 days after the last dose of study drug, from the list below:
Key exclusion criteria (28 listed)
- Current or previous cancer, excluding basal cell carcinoma that has been in remission for >5 years prior to dosing and in situ cervical carcinoma; diabetes or known diagnosis of prediabetes; or any clinically significant cardiovascular (including ECG disturbances or history of rhythm disturbance/abnormality), endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder.
- Hypertension, defined as blood pressure >140/90 mmHg (2 separate readings at least 15 minutes apart if first reading is not within normal range).
- Hyperlipidemia defined as
- Hemoglobin A1c (HbA1c) >6.5% at Screening. Note: Abnormal laboratory values may be repeated once at Investigator discretion.
- Hemoglobin or hematocrit outside upper and lower limits of normal range per reference laboratory range at both Screening and Day -1 (Admission).
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 |
|---|---|---|
| STP707STP707 Powder for Injection, contains 2 (siRNA) and (HKP+H) delivery system. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Evaluate safety & tolerability of STP707 when administered by IV in healthy subjects
Time frame: 60 DAys
Number and percentage of subjects in total experiencing treatment-emergent (AEs) from baseline.
Evaluate safety & tolerability of STP707 when administered by IV in healthy subjects
Time frame: 60 days
Number and percentage of subjects in each dose cohort experiencing treatment-emergent (AEs) from baseline.
1 secondary outcome
Evaluate (PK) of STP707 when administered by IV in healthy subjects
Time frame: 60 Days
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 18 Mar 2024.
- 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.
Francois Lebel, MD study director
Chief Medical Officer
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 STP707 in people with Healthy Subjects, run by Sirnaomics 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 14 inclusion and 28 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 18 Mar 2024. 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?
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?
Evaluate safety & tolerability of STP707 when administered by IV in healthy subjects (time frame: 60 DAys). The study lists 2 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 18 Mar 2024.