HealthyPhase 1NCT04971135
First-in-human Study of SAN711 in Healthy Participants
A Phase 1 study testing SAN711 in people with Healthy, run by Saniona at 1 site in United Kingdom.
Trial summary
Phase 1, first-in-human, double-blind, randomized, placebo-controlled, parallel group, single ascending dose (SAD) and multiple ascending dose (MAD) study Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SAN711
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2021to Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, determined by Screening medical evaluation (medical history, physical examination, vital signs, safety 12-lead electrocardiogram [ECG], and clinical laboratory evaluations, including liver and renal function tests which must be within normal limits)
- Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive at Screening
- Non-smoker (and no other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (<500 ng/mL) at the Screening Visit and admission
- Female participants must be women of non-childbearing potential (WONCBP); defined as follows: surgically sterile (ie, had a hysterectomy, or bilateral oophorectomy, or bilateral salpingectomy ≥6 months prior to the first dose of study drug); or Postmenopausal (no menses) for at least 1 year prior to the first dose of study drug. Postmenopausal status must be confirmed by FSH testing at screening
Who cannot join
- Participant has a history or evidence of any clinically significant cardiovascular, general gastrointestinal, endocrine, hematologic, hepatic, immunological, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the investigator
- Participant answers "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the Columbia Suicide Severity Rating Scale
- Participant's current alcohol intake exceeds 14 units/week for men and women (1 unit = half pint of beer, 1 glass of wine, 1 measure of spirits)
- Participant is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to check-in Day and until final discharge Day inclusive
- Participant is unwilling to avoid consumption of caffeine-containing beverages within 48 hours prior to day of admission until final discharge day
- Participant has a history of illicit substance use OR a positive urine drug test (eg, cocaine, amphetamines, methylenedioxymethamphetamine (MDMA), barbiturates, opiates, benzodiazepines, or cannabinoids) or urine alcohol test at the Screening Visit or admission
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- Participant has a positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C, or HBsAg negative/anti-HBc positive/anti-HBs negative, or human immunodeficiency virus (HIV) 1 and/or -2 antibodies
- At Screening and Baseline, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, or diastolic blood pressure (DBP) greater than 90 or less than 40 mm Hg, in the supine position, at screening or baseline. Borderline values (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) will be repeated. Subjects can be included if the repeat value is within range or still borderline, but deemed not clinically significant by the investigator
- Corrected QT interval using Fridericia's formula >450 msec for males and >470 msec for females
- Resting bradycardia (heart rate [HR] <40 beats per minute [bpm]) or tachycardia (HR >100 bpm)
- Personal or family history of congenital long QT syndrome or sudden death
- Screening or Admission ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate QT measurement (eg, neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves)
- Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker at screening or on admission
- Receipt of COVID-19 vaccine within 2 weeks prior to baseline or scheduled for vaccination during the study
- COVID-19 infection within 90 days of screening or evidence of current COVID-19 infection within the past 4 weeks at screening, between screening and admission, or at admission
- If unvaccinated for COVID-19, contact with an individual with COVID-19 infection in the past 14 days at screening, between screening and admission, or at admission
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Medicines Research (HMR)
London, NW10 7EW
Malcolm Boyce, MD, 020 8961 4130
About this study
Official title: A Phase 1 Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of SAN711 in Healthy Participants
Phase 1, first-in-human, double-blind, randomized, placebo-controlled, parallel group, single ascending dose (SAD) and multiple ascending dose (MAD) study
- Conditions
- Healthy
- Being tested
- SAN711, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAN711Drug
SAN711 liquid formulation
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| SAN711 (SAD) | Experimental | 6 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of SAN711 Receives: Drug: SAN711 |
| Placebo (SAD) | Placebo comparator | 2 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of Placebo Receives: Other: Placebo |
| SAN711 (MAD) | Experimental | 6 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of SAN711 Receives: Drug: SAN711 |
| Placebo (MAD) | Placebo comparator | 2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events (TEAEs) [SAD]
Incidence of TEAEs during SAD
Measured: Initiation of dosing through 96 hours post dosing
TEAEs [MAD]
Incidence of TEAEs during MAD
Measured: Initiation of dosing through 16 days post dosing
Adverse Events of Special Interest (AESIs) [SAD]
Incidence of AESIs during SAD
Measured: Initiation of dosing through 96 hours post dosing
AESIs [MAD]
Incidence of AESIs during MAD
Measured: Initiation of dosing through 16 days post dosing
Secondary outcomes (10)
PK Parameters: Cmax [SAD]
Maximum observed plasma concentration at Tmax during SAD
Measured: Baseline (Predose) through 96 hours post dosing
PK Parameters: Cmax [MAD]
Maximum observed plasma concentration at Tmax during MAD
Measured: Day 1 (Predose) through Day 16
PK Parameters: Tmax [SAD]
Time of maximum observed plasma concentration during SAD
Measured: Baseline (Predose) through 96 hours post dosing
PK Parameters: Tmax [MAD]
Time of maximum observed plasma concentration during MAD
Measured: Day 1 (Predose) through Day 16
PK Parameters: t1/2 [SAD]
Apparent terminal phase half-life during SAD
Measured: Baseline (Predose) through 96 hours post dosing
PK Parameters: t1/2 [MAD]
Apparent terminal phase half-life during MAD
Measured: Day 1 (Predose) through Day 16
PK Parameters: AUC-last [SAD]
Area under the plasma concentration time curve from time zero to T-last, the time at which Last measurable plasma concentration (C-last) is observed during SAD
Measured: Baseline (Predose) through 96 hours post dosing
PK Parameters: AUC-last [MAD]
Area under the plasma concentration time curve from time zero to T-last, the time at which Last measurable plasma concentration (C-last) is observed during MAD
Measured: Day 1 (Predose) through Day 16
PK Parameters: AUC-inf [SAD]
Area under the plasma concentration time curve extrapolated to infinity during SAD
Measured: Baseline (Predose) through 96 hours post dosing
PK Parameters: AUC-inf [MAD]
Area under the plasma concentration time curve extrapolated to infinity during MAD
Measured: Day 1 (Predose) through Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start30 Jun 2021
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saniona
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971135
- Sponsor's protocol ID
- SAN711-01
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Sponsor will consider requests for access to SAN711-01 Study materials following completion of SAN711 Development
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of SAN711 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04971135
- Acronym / sponsor ID
- SAN711-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SanionaIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 21 Jul 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.
Phase 1, first-in-human, double-blind, randomized, placebo-controlled, parallel group, single ascending dose (SAD) and multiple ascending dose (MAD) study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAN711 (SAD) | Experimental | Drug: SAN7116 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of SAN711 |
| Placebo (SAD) | Placebo comparator | Other: Placebo2 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of Placebo |
| SAN711 (MAD) | Experimental | Drug: SAN7116 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of SAN711 |
| Placebo (MAD) | Placebo comparator | Other: Placebo2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy, determined by Screening medical evaluation (medical history, physical examination, vital signs, safety 12-lead electrocardiogram [ECG], and clinical laboratory evaluations, including liver and renal function tests which must be within normal limits)
- Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive at Screening
- Non-smoker (and no other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (<500 ng/mL) at the Screening Visit and admission
- Female participants must be women of non-childbearing potential (WONCBP); defined as follows: surgically sterile (ie, had a hysterectomy, or bilateral oophorectomy, or bilateral salpingectomy ≥6 months prior to the first dose of study drug); or Postmenopausal (no menses) for at least 1 year prior to the first dose of study drug. Postmenopausal status must be confirmed by FSH testing at screening
Key exclusion criteria (16 listed)
- Participant has a history or evidence of any clinically significant cardiovascular, general gastrointestinal, endocrine, hematologic, hepatic, immunological, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the investigator
- Participant answers "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the Columbia Suicide Severity Rating Scale
- Participant's current alcohol intake exceeds 14 units/week for men and women (1 unit = half pint of beer, 1 glass of wine, 1 measure of spirits)
- Participant is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to check-in Day and until final discharge Day inclusive
- Participant is unwilling to avoid consumption of caffeine-containing beverages within 48 hours prior to day of admission until final discharge day
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 |
|---|---|---|
| SAN711SAN711 liquid formulation | Drug | SAN711 (MAD), SAN711 (SAD) |
| PlaceboMatching placebo | Other | Placebo (MAD), Placebo (SAD) |
Primary outcome
Treatment-emergent Adverse Events (TEAEs) [SAD]
Time frame: Initiation of dosing through 96 hours post dosing
Incidence of TEAEs during SAD
TEAEs [MAD]
Time frame: Initiation of dosing through 16 days post dosing
Incidence of TEAEs during MAD
Adverse Events of Special Interest (AESIs) [SAD]
Time frame: Initiation of dosing through 96 hours post dosing
Incidence of AESIs during SAD
AESIs [MAD]
Time frame: Initiation of dosing through 16 days post dosing
Incidence of AESIs during MAD
10 secondary outcomes
PK Parameters: Cmax [SAD]
Time frame: Baseline (Predose) through 96 hours post dosing
PK Parameters: Cmax [MAD]
Time frame: Day 1 (Predose) through Day 16
PK Parameters: Tmax [SAD]
Time frame: Baseline (Predose) through 96 hours post dosing
PK Parameters: Tmax [MAD]
Time frame: Day 1 (Predose) through Day 16
PK Parameters: t1/2 [SAD]
Time frame: Baseline (Predose) through 96 hours post dosing
PK Parameters: t1/2 [MAD]
Time frame: Day 1 (Predose) through Day 16
PK Parameters: AUC-last [SAD]
Time frame: Baseline (Predose) through 96 hours post dosing
PK Parameters: AUC-last [MAD]
Time frame: Day 1 (Predose) through Day 16
PK Parameters: AUC-inf [SAD]
Time frame: Baseline (Predose) through 96 hours post dosing
PK Parameters: AUC-inf [MAD]
Time frame: Day 1 (Predose) through Day 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: Yes. The Sponsor will consider requests for access to SAN711-01 Study materials following completion of SAN711 Development
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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.
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 SAN711 in people with Healthy, run by Saniona 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 21 Jul 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol Lewis-Cullinan (1 781 839 9100, clinicalstudy@saniona.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent Adverse Events (TEAEs) [SAD] (time frame: Initiation of dosing through 96 hours post dosing). 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 21 Jul 2021.