Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers

NCT05364840 | Completed Phase 1

• 1 other identifier: MPR-COV-101AU
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, two-part, randomized, double blind, placebo controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetics of STI-1558 administered orally to healthy volunteers.

Conditions

COVID-19

Keywords

covid19; COVID-19

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs) (safety)

  Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5) Safety as assessed by incidence of adverse events, clinically significant changes in safety lab results, physical exam, vital signs, and electrocardiogram

  baseline through study completion at up to 42 days

• Cardiac function (safety)

  Heart function as assessed by 12-lead electrocardiogram

  baseline through study completion at up to 42 days

Secondary Outcomes (4)

• AUC of STI-1558 (PK)

  baseline through study completion at up to 42 days

• Cmax of STI-1558

  baseline through study completion at up to 42 days

• t1/2 of STI-1558

  baseline through study completion at up to 42 days

• Tmax of STI-1558

  baseline through study completion at up to 42 days

Study Arms (2)

STI-1558

EXPERIMENTAL

Subjects will receive in each part either a single ascending dose (SAD): 300 mg, 600 mg, 1200 mg, 2000 mg on Day1 or as part of the multiple ascending dose (MAD): 300 mg, 600 mg, and 800 mg twice a day for 7.5 days

Drug: STI-1558

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo orally following either the SAD or MAD dosing schedule

Drug: Placebo

Interventions

STI-1558 DRUG

Orally available protease inhibitor capsule

STI-1558

Placebo DRUG

Placebo product capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) is between 18 and 30 kg/m2 (both inclusive), and Body weight between 45 and 100 kg (inclusive)
• Generally normal, or abnormal with no clinical significance as judged by the primary investigator based on physical examination, vital signs, electrocardiogram, and clinical laboratory tests
• Willing to follow contraception guidelines
• Willing and able to comply with study procedures and follow-up visits

You may not qualify if:

• Difficulty or history of dizziness during venous blood collection or encountering blood or needles
• Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding
• A clinically relevant intolerance or allergy to drugs, or are known or suspected to have hypersensitivity to any ingredient in STI-1558 capsules
• Received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior to the first dose of study drug
• Has a history of gastrointestinal, liver or kidney disease, or other condition that may exclude the subject as determined by the investigator
• Has a medical history of significant diseases as determined by the investigator
• Has a history of febrile illness within 14 days prior to the first dose of study drug
• Has values above the upper limit of normal alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase at screening or Day -1 and judged to be clinically significant by the investigator
• Prolonged QTcF interval
• Has had major surgery within 3 months prior to the first dose of study drug or plans to undergo surgery during the study
• Any marketed medication within 14 days or 5 times the half-life, whichever is longer, prior to the first dose of study drug
• Vaccinated within 14 days prior to the first dose of study drug or plans to be vaccinated during the study
• Is unwilling to abstain from quinine containing products or grapefruit during the study
• Use of BCRP substrates within 7 days prior to the first dose of study drug
• A known history of drug abuse within 2 years before screening or positive drug abuse test at screening

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

Related Publications (1)

• Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.

  PMID: 38181791 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

STI-1558

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 6, 2022
• Study Start: June 7, 2022
• Primary Completion: October 18, 2022
• Study Completion: November 4, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

AU (1)