COVID 19Phase 1NCT06698549

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function

A Phase 1 study testing ALG-097558 in people with COVID 19, run by Aligos Therapeutics at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: COVID 19
What is being tested?: ALG-097558
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 3 sitesUnited States
Study dates: 20 Feb 2025to 13 Aug 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and Female between 18 and 75 years old
Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)
Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy
Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment
Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
Normal renal function (estimated Glomerular Filtration Rate [eGFR] ≥90 mL/min) with no known or suspected renal impairment

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Inclusion Criteria for Subjects with Impaired Renal Function:
Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration
Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening
Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria

Who cannot join

Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results and interpretation
Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc.
Subjects with a history of clinically significant drug allergy
Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up

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Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >2x upper limit of normal (ULN)
Subjects with bilirubin (total, direct) >1.5x ULN (unless Gilbert's is suspected)
Positive pregnancy test; females must not be pregnant at enrollment
1. Hemoglobin <10 g/dL
Exclusion Criteria for Subjects with Impaired Renal Function:
Participants requiring hemodialysis and/or peritoneal dialysis
Hemoglobin <9 g/dL

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
Genesis Clinical Trials
Tampa, Florida, 33603

Other trials in United States

About this study

Official title: A Phase 1 Non-Randomized, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal 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 renal impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Conditions: COVID 19
Being tested: ALG-097558
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALG-097558Drug
Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)

Study groups in NCT06698549
Study group	Role	What they receive
Subjects with Severe Renal Impairment	Experimental	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses. Receives: Drug: ALG-097558
Subjects with Normal Renal Function	Experimental	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses. Receives: Drug: ALG-097558
Subjects with Mild Renal Impairment (Optional)	Experimental	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses. Receives: Drug: ALG-097558
Subjects with Moderate Renal Impairment (Optional)	Experimental	Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses. Receives: Drug: ALG-097558

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration Time Curve [AUC]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only
C0 [Predose]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: Pre-dose (-0.75 hours) up to Day 8
Half-life [t1/2]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Time to Maximum Plasma Concentration [Tmax]
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Apparent Clearance (CL/F)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Apparent Volume of Distribution (V/F)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Measured: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Total Amount of Drug Excreted in Urine (Ae)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Measured: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose
Renal Clearance (CLr)
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Measured: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose.

Secondary outcomes (1)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1 (July 2017)
Measured: Up to 20 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 202513 Aug 2025

First posted21 Nov 2024
Study start20 Feb 2025
Primary completion23 Jul 2025
Study completion13 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID 19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This study is non-randomized, open-label, parallel group study. In Part 1, Cohort 1 will enroll severely renally impaired subjects and Cohort 2 will enroll subjects without renal impairment. In Part 2, if triggered, Cohort 3 will enroll mildly renally impaired subjects and Cohort 4 moderately renally impaired subjects. Cohort 5 will enroll subjects without renal impairment.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06698549
Sponsor's protocol ID: ALG-097558-703 / DMID 24-0022
Status last verified: May 2026
First submitted: 12 Nov 2024
Last updated: 25 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID 19 trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Non-Randomized, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function
ClinicalTrials.gov ID: NCT06698549
Acronym / sponsor ID: ALG-097558-703 / DMID 24-0022
Conditions: COVID 19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Aligos TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 20 Feb 2025 (actual)
Primary completion: 23 Jul 2025 (actual)
Study completion: 13 Aug 2025 (actual)
First posted: 21 Nov 2024 (actual)
Results: Posted 9 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: This study is non-randomized, open-label, parallel group study. In Part 1, Cohort 1 will enroll severely renally impaired subjects and Cohort 2 will enroll subjects without renal impairment. In Part 2, if triggered, Cohort 3 will enroll mildly renally impaired subjects and Cohort 4 moderately renally impaired subjects. Cohort 5 will enroll subjects without renal impairment.

Arm	Type	Receives
Subjects with Severe Renal Impairment	Experimental	Drug: ALG-097558Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
Subjects with Normal Renal Function	Experimental	Drug: ALG-097558Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
Subjects with Mild Renal Impairment (Optional)	Experimental	Drug: ALG-097558Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
Subjects with Moderate Renal Impairment (Optional)	Experimental	Drug: ALG-097558Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male and Female between 18 and 75 years old
Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)
Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy
Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment
Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender

Key exclusion criteria (14 listed)

Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results and interpretation
Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc.
Subjects with a history of clinically significant drug allergy
Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALG-097558Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)	Drug	Subjects with Mild Renal Impairment (Optional), Subjects with Moderate Renal Impairment (Optional), Subjects with Normal Renal Function, Subjects with Severe Renal Impairment

Primary outcome

Area Under the Concentration Time Curve [AUC]
Time frame: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Maximum Plasma Concentration [Cmax]
Time frame: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Minimum Plasma Concentration [Cmin]
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
C0 [Predose]
Time frame: Pre-dose (-0.75 hours) up to Day 8
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Half-life [t1/2]
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Time to Maximum Plasma Concentration [Tmax]
Time frame: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Apparent Clearance (CL/F)
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Apparent Volume of Distribution (V/F)
Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Total Amount of Drug Excreted in Urine (Ae)
Time frame: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Renal Clearance (CLr)
Time frame: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

1 secondary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 20 Days

Results and safety

Results posted to the registry on 9 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With Severe Renal Impairment	6	6
Subjects With Normal Renal Function	6	5
Subjects With Mild Renal Impairment (Optional)	0	0
Subjects With Moderate Renal Impairment (Optional)	0	0

Primary outcome: Area Under the Concentration Time Curve [AUC]

Time frame: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only. Geometric mean (Geometric Coefficient of Variation). Unit: ng.h/mL

Measure	Subjects With Severe Renal Impairment n = 6	Subjects With Normal Renal Function n = 6	Subjects With Mild Renal Impairment (Optional) n = 0	Subjects With Moderate Renal Impairment (Optional) n = 0
Total ALG-097558 - AUC0-12 Day 1	27000 (71.6)	14300 (34.4)	–	–
Total ALG-097558 - AUC0-12 Day 6	21100 (53.0)	14300 (35.5)	–	–
Unbound ALG-097558 - AUC0-12 Day 1	1070 (74.7)	561 (58.0)	–	–
Unbound ALG-097558 - AUC0-12 Day 6	857 (50.1)	694 (25.8)	–	–
Total ALG-097730 - AUC0-12 Day 1	6040 (65.7)	3260 (28.4)	–	–
Total ALG-097730 - AUC0-12 Day 6	5650 (62.3)	3490 (28.2)	–	–
Unbound ALG-097730 - AUC0-12 Day 1	1130 (73.0)	630 (54.2)	–	–
Unbound ALG-097730 - AUC0-12 Day 6	992 (67.1)	620 (43.3)	–	–

Population analysed: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.

Primary outcome: Maximum Plasma Concentration [Cmax]

Time frame: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Subjects With Severe Renal Impairment n = 6	Subjects With Normal Renal Function n = 6	Subjects With Mild Renal Impairment (Optional) n = 0	Subjects With Moderate Renal Impairment (Optional) n = 0
Total ALG-097558 - Cmax Day 1	5260 (55.8)	3500 (35.7)	–	–
Total ALG-097558 - Cmax Day 6	3870 (38.6)	3040 (45.0)	–	–
Unbound ALG-097558 - Cmax Day 1	252 (58.3)	182 (50.9)	–	–
Unbound ALG-097558 - Cmax Day 6	178 (44.7)	147 (47.7)	–	–
Total ALG-097730 - Cmax Day 1	893 (45.8)	611 (31.9)	–	–
Total ALG-097730 - Cmax Day 6	853 (46.5)	584 (36.8)	–	–
Unbound ALG-097730 - Cmax Day 1	194 (49.1)	144 (49.8)	–	–
Unbound ALG-097730 - Cmax Day 6	179 (47.1)	123 (59.9)	–	–

Primary outcome: Minimum Plasma Concentration [Cmin]

Time frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Subjects With Severe Renal Impairment n = 6	Subjects With Normal Renal Function n = 6	Subjects With Mild Renal Impairment (Optional) n = 0	Subjects With Moderate Renal Impairment (Optional) n = 0
Total ALG-097558 - Cmin Day 6	326 (108)	160 (38.0)	–	–
Total ALG-097730 - Cmin Day 6	154 (100)	75.0 (35.5)	–	–

Primary outcome: C0 [Predose]

Time frame: Pre-dose (-0.75 hours) up to Day 8. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Subjects With Severe Renal Impairment n = 6	Subjects With Normal Renal Function n = 6	Subjects With Mild Renal Impairment (Optional) n = 0	Subjects With Moderate Renal Impairment (Optional) n = 0
Total ALG-097558 - Ctrough Day 2	509 (122)	226 (30.7)	–	–
Total ALG-097558 - Ctrough Day 3	464 (59.5)	323 (44.3)	–	–
Total ALG-097558 - Ctrough Day 4	542 (89.4)	372 (46.4)	–	–
Total ALG-097558 - Ctrough Day 5	424 (67.5)	295 (108)	–	–
Total ALG-097558 - Ctrough Day 6	623 (66.6)	321 (58.3)	–	–
Unbound ALG-097558 - Ctrough Day 2	29.4 (69.7)	NA	–	–
Unbound ALG-097558 - Ctrough Day 3	15.0 (67.0)	11.7 (4.55)	–	–
Unbound ALG-097558 - Ctrough Day 4	20.9 (61.6)	13.5 (14.3)	–	–

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 20 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With Severe Renal Impairment	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Subjects With Normal Renal Function	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Subjects With Mild Renal Impairment (Optional)	0 of 0	0 of 0	0
Subjects With Moderate Renal Impairment (Optional)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALG-097558 in people with COVID 19, run by Aligos Therapeutics at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration Time Curve [AUC] (time frame: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06698549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.