First-in-human Study of SAN711 in Healthy Participants

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Drug: SAN711

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Carol Lewis-Cullinan; Phone Number: 1 781 839 9100; Email: clinicalstudy@saniona.com

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • Recruiting
    • Hammersmith Medicines Research (HMR)
    • Contact: Malcolm Boyce, MD; Phone Number: 020 8961 4130

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent Adverse Events (TEAEs) [SAD]	Incidence of TEAEs during SAD	Initiation of dosing through 96 hours post dosing
TEAEs [MAD]	Incidence of TEAEs during MAD	Initiation of dosing through 16 days post dosing
Adverse Events of Special Interest (AESIs) [SAD]	Incidence of AESIs during SAD	Initiation of dosing through 96 hours post dosing
AESIs [MAD]	Incidence of AESIs during MAD	Initiation of dosing through 16 days post dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Parameters: Cmax [SAD]	Maximum observed plasma concentration at Tmax during SAD	Baseline (Predose) through 96 hours post dosing
PK Parameters: Cmax [MAD]	Maximum observed plasma concentration at Tmax during MAD	Day 1 (Predose) through Day 16
PK Parameters: Tmax [SAD]	Time of maximum observed plasma concentration during SAD	Baseline (Predose) through 96 hours post dosing
PK Parameters: Tmax [MAD]	Time of maximum observed plasma concentration during MAD	Day 1 (Predose) through Day 16
PK Parameters: t1/2 [SAD]	Apparent terminal phase half-life during SAD	Baseline (Predose) through 96 hours post dosing
PK Parameters: t1/2 [MAD]	Apparent terminal phase half-life during MAD	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	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	Day 1 (Predose) through Day 16
PK Parameters: AUC-inf [SAD]	Area under the plasma concentration time curve extrapolated to infinity during SAD	Baseline (Predose) through 96 hours post dosing
PK Parameters: AUC-inf [MAD]	Area under the plasma concentration time curve extrapolated to infinity during MAD	Day 1 (Predose) through Day 16

Collaborators and Investigators

• Sponsor: Saniona
• Collaborators: Medpace, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (ACTUAL): July 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SAN711-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Sponsor will consider requests for access to SAN711-01 Study materials following completion of SAN711 Development
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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