Apply to Trial

Compensation: Varies

Number of Visits: 2

Duration: 1 week

16 Participants Needed

ALG-097558 for Coronavirus

Recruiting at 1 trial location

Overseen ByJen Rito

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aligos Therapeutics

Disqualifiers: Cardiac disease, Drug abuse, Alcohol use, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants with impaired liver function should have stable medications for at least 28 days before the trial, suggesting you may need to continue your current medications if they are stable.

How does the drug ALG-097558 differ from other COVID-19 treatments?

ALG-097558 is unique because it is based on aloperine derivatives that inhibit the entry of the SARS-CoV-2 virus into host cells, preventing the virus from fusing with cell membranes. This mechanism of action is different from other treatments like monoclonal antibodies, which typically neutralize the virus by binding to its spike protein.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Eligibility Criteria

This trial is for adults with moderate liver problems (hepatic impairment) and healthy adults with normal liver function. Participants should match in age, weight, and possibly gender. It's not clear what specific conditions exclude someone from this trial since the exclusion criteria are not provided.

Inclusion Criteria

My liver functions normally.

Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria

I am not able to have children or will use effective birth control.

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Exclusion Criteria

Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up

I have a history of heart rhythm problems or risk factors for severe arrhythmias.

Bilirubin (total, direct) >1.2× upper limit of normal (ULN) (unless Gilbert's is suspected)

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of 200 mg ALG-097558 twice daily for 6 days

1 week

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person)

Treatment Details

Interventions

ALG-097558

Trial Overview The study is testing ALG-097558, a drug given orally twice daily to see how different levels of liver health affect its presence in the blood over time. This non-randomized study involves both people with moderate liver issues and those without any.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Subjects with Normal Hepatic FunctionExperimental Treatment1 Intervention

Subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Group II: Subjects with Moderate Hepatic Impairment (Child-Pughs Class B)Experimental Treatment1 Intervention

Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aligos Therapeutics

Lead Sponsor

Trials

Recruited

960+

Founded

2018

Headquarters

South San Francisco, United States

Known For

Liver & Viral Therapies

Findings from Research

A new derivative of aloperine, identified as Compound 5, has shown strong antiviral activity against SARS-CoV-2, with an IC50 of 0.5 µM, making it the most potent variant tested against the virus.

Compound 5 effectively inhibits the entry of SARS-CoV-2 into host cells before the virus can fuse with the cell membrane, indicating its potential as a therapeutic agent against multiple variants, including Delta and Omicron.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quinolizidines as Novel SARS-CoV-2 Entry Inhibitors.Huang, L., Zhu, L., Xie, H., et al.[2023]

AZD7442, a combination of two monoclonal antibodies, effectively prevents SARS-CoV-2 infection and accelerates virus clearance in nonhuman primates, indicating its potential for both prevention and treatment of COVID-19.

In a phase 1 study with healthy participants, a single 300-mg injection of AZD7442 resulted in neutralizing antibody levels significantly higher than those found in convalescent serum, providing protection for at least 9 months, suggesting it could be a long-lasting option for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans.Loo, YM., McTamney, PM., Arends, RH., et al.[2023]

In a phase 3 trial involving 1121 adults, AZD7442 (tixagevimab/cilgavimab) did not meet the primary endpoint of significantly preventing symptomatic COVID-19 compared to placebo, with only a 33.3% relative risk reduction observed.

However, among participants who were SARS-CoV-2 RT-PCR-negative or had missing results at baseline, AZD7442 showed a promising 73.2% reduction in symptomatic COVID-19, suggesting its potential effectiveness in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AZD7442 (Tixagevimab/Cilgavimab) for Post-Exposure Prophylaxis of Symptomatic Coronavirus Disease 2019.Levin, MJ., Ustianowski, A., Thomas, S., et al.[2023]