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Trial record 1 of 1 for:    SAN711
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First-in-human Study of SAN711 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT04971135
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Saniona

Brief Summary:
Phase 1, first-in-human, double-blind, randomized, placebo-controlled, parallel group, single ascending dose (SAD) and multiple ascending dose (MAD) study

Condition or disease Intervention/treatment Phase
Healthy Drug: SAN711 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1 Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of SAN711 in Healthy Participants
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: SAN711 (SAD)
6 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of SAN711
Drug: SAN711
SAN711 liquid formulation

Placebo Comparator: Placebo (SAD)
2 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of Placebo
Other: Placebo
Matching placebo

Experimental: SAN711 (MAD)
6 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of SAN711
Drug: SAN711
SAN711 liquid formulation

Placebo Comparator: Placebo (MAD)
2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 14 daily doses of Placebo
Other: Placebo
Matching placebo




Primary Outcome Measures :
  1. Treatment-emergent Adverse Events (TEAEs) [SAD] [ Time Frame: Initiation of dosing through 96 hours post dosing ]
    Incidence of TEAEs during SAD

  2. TEAEs [MAD] [ Time Frame: Initiation of dosing through 16 days post dosing ]
    Incidence of TEAEs during MAD

  3. Adverse Events of Special Interest (AESIs) [SAD] [ Time Frame: Initiation of dosing through 96 hours post dosing ]
    Incidence of AESIs during SAD

  4. AESIs [MAD] [ Time Frame: Initiation of dosing through 16 days post dosing ]
    Incidence of AESIs during MAD


Secondary Outcome Measures :
  1. PK Parameters: Cmax [SAD] [ Time Frame: Baseline (Predose) through 96 hours post dosing ]
    Maximum observed plasma concentration at Tmax during SAD

  2. PK Parameters: Cmax [MAD] [ Time Frame: Day 1 (Predose) through Day 16 ]
    Maximum observed plasma concentration at Tmax during MAD

  3. PK Parameters: Tmax [SAD] [ Time Frame: Baseline (Predose) through 96 hours post dosing ]
    Time of maximum observed plasma concentration during SAD

  4. PK Parameters: Tmax [MAD] [ Time Frame: Day 1 (Predose) through Day 16 ]
    Time of maximum observed plasma concentration during MAD

  5. PK Parameters: t1/2 [SAD] [ Time Frame: Baseline (Predose) through 96 hours post dosing ]
    Apparent terminal phase half-life during SAD

  6. PK Parameters: t1/2 [MAD] [ Time Frame: Day 1 (Predose) through Day 16 ]
    Apparent terminal phase half-life during MAD

  7. PK Parameters: AUC-last [SAD] [ Time Frame: Baseline (Predose) through 96 hours post dosing ]
    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

  8. PK Parameters: AUC-last [MAD] [ Time Frame: Day 1 (Predose) through Day 16 ]
    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

  9. PK Parameters: AUC-inf [SAD] [ Time Frame: Baseline (Predose) through 96 hours post dosing ]
    Area under the plasma concentration time curve extrapolated to infinity during SAD

  10. PK Parameters: AUC-inf [MAD] [ Time Frame: Day 1 (Predose) through Day 16 ]
    Area under the plasma concentration time curve extrapolated to infinity during MAD



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971135


Contacts
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Contact: Carol Lewis-Cullinan 1 781 839 9100 clinicalstudy@saniona.com

Locations
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United Kingdom
Hammersmith Medicines Research (HMR) Recruiting
London, United Kingdom, NW10 7EW
Contact: Malcolm Boyce, MD    020 8961 4130      
Sponsors and Collaborators
Saniona
Medpace, Inc.
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Responsible Party: Saniona
ClinicalTrials.gov Identifier: NCT04971135    
Other Study ID Numbers: SAN711-01
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Sponsor will consider requests for access to SAN711-01 Study materials following completion of SAN711 Development
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No