First-in-human Study of SAN711 in Healthy Participants

NCT04971135 | Unknown Phase 1 DMC

• 1 other identifier: SAN711-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• PK Parameters: Cmax [SAD]

  Baseline (Predose) through 96 hours post dosing

• PK Parameters: Cmax [MAD]

  Day 1 (Predose) through Day 16

• PK Parameters: Tmax [SAD]

  Baseline (Predose) through 96 hours post dosing

• PK Parameters: Tmax [MAD]

  Day 1 (Predose) through Day 16

• PK Parameters: t1/2 [SAD]

  Baseline (Predose) through 96 hours post dosing

Study Arms (4)

SAN711 (SAD)

EXPERIMENTAL

6 out of 8 participants per cohort (up to 7 cohorts) will be randomized to receive a single dose of SAN711

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

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

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

Other: Placebo

Interventions

SAN711 DRUG

SAN711 liquid formulation

SAN711 (MAD); SAN711 (SAD)

Placebo OTHER

Matching placebo

Placebo (MAD); Placebo (SAD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saniona: lead
• Medpace, Inc.: collaborator

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

RECRUITING

Central Study Contacts

Carol Lewis-Cullinan

CONTACT

1 781 839 9100; clinicalstudy@saniona.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 21, 2021
• Study Start: June 30, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GB (1)