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Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19

NCT05212662 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-10-01

No results posted yet for this study

Summary

This is multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacodynamics (PD) and efficacy of TTI-0102 for the treatment of patients with mild to moderate COVID-19. This is a phase 2 study of cysteamine-pantetheine disulfide (TTI-0102), an antiviral, anti-infectious, antioxidant and anti-CRS (cytokine release syndrome) investigational drug. Subjects will be randomized 2:1 to receive TTI-0102 or placebo daily for up to 14 days. Up to 5 centers in the US and Canada will conduct this study. 60 patients will be enrolled.

Conditions

  • COVID-19
  • COVID-19 Acute Respiratory Distress Syndrome

Interventions

DRUG

TTI-0102

The study treatment is a precursor to cysteamine, TTI-0102 (cysteamine-pantetheine disulfide). Each molecule of TTI-0102, after reduction and metabolism in the digestive tract, allows the absorption of 2 molecules of cysteamine and one molecule of pantothenic acid (Vit B5). Each dose of TTI-0102 comes in a vial as a powder to dissolve in water and absorb orally. Each vial contains 5.5g of TTI-0102, corresponding to the equivalent of 2.4g of cysteamine base. This single dose is less than the maximum daily dose authorized with other formulations of cysteamine (Cystagon or Procysbi, 1.95 g/m2/day) for patients over 1.25 m2 or 40 kg (88 lbs). This dose of 5.5 g is justified by the need to maintain a thiol/disulfide ratio in favor of cysteamine over 24 h. It has been tested in healthy volunteers and has no side effects due to the specific pharmacokinetics of cysteamine after administration of TTI-0102.

DRUG

Placebo

Placebo comparator supplied in vials identical to the active intervention, TTI-0102

Sponsors & Collaborators

  • Thiogenesis Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrice P Rioux, MD, PhD · Sponsor: Thiogenesis Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2024-09-27
Completion
2024-09-27
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05212662 on ClinicalTrials.gov