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CompletedNCT06698549Updated Aug 25, 2026Results posted

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 interventional study of ALG-097558 in COVID 19, sponsored by Aligos Therapeutics. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Aligos Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • COVID 19

Browse trials for

03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 12 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Aligos Therapeutics is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and Female between 18 and 75 years old
  2. (BMI) 17.5 to 40.0 kg/m\^2 and a total body weight >50 kg (110 lb)
  3. Female subjects must either be not of 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 therapy

Inclusion Criteria for Subjects with Normal Renal Function:

  1. Good general health as defined by no abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead (ECG) assessment
  2. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
  3. Normal renal function (estimated [eGFR] ≥90 mL/min) with no known or suspected renal impairment

Inclusion Criteria for Subjects with Impaired Renal Function:

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

Exclusion criteria

Exclusion Criteria for All Subjects:

  1. 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
  2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long Syndrome) or history or clinical evidence at screening of significant (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc.
  3. Subjects with a history of drug allergy
  4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
  5. Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
  6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up
  7. Subjects with Hepatitis A, B, C, E or -1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
  8. Subjects with (ALT) or aspartate aminotransferase (AST) values >2x (ULN)
  9. Subjects with (total, direct) >1.5x ULN (unless Gilbert's is suspected)
  10. Positive pregnancy test; females must not be pregnant at enrollment

Exclusion Criteria for Subjects with Normal Renal Function:

1. \<10 g/dL

Exclusion Criteria for Subjects with Impaired Renal Function:

  1. Participants requiring hemodialysis and/or peritoneal dialysis
  2. Hemoglobin \<9 g/dL
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Subjects with Severe Renal Impairment

    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.

    Drug: ALG-097558

  • Experimental
    Subjects with Normal Renal Function

    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.

    Drug: ALG-097558

  • Experimental
    Subjects with Mild Renal Impairment (Optional)

    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.

    Drug: ALG-097558

  • Experimental
    Subjects with Moderate Renal Impairment (Optional)

    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.

    Drug: ALG-097558

Interventions

  • DrugALG-097558

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

06

What researchers measure

Primary outcomes

  1. Area Under the Concentration Time Curve [AUC]

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    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

  2. Maximum Plasma Concentration [Cmax]

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    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

  3. Minimum Plasma Concentration [Cmin]

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    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

  4. C0 [Predose]

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    Time frame: Pre-dose (-0.75 hours) up to Day 8

  5. Half-life [t1/2]

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    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

  6. Time to Maximum Plasma Concentration [Tmax]

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    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

  7. Apparent Clearance (CL/F)

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    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

  8. Apparent Volume of Distribution (V/F)

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

    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

  9. Total Amount of Drug Excreted in Urine (Ae)

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

    Time frame: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose

  10. Renal Clearance (CLr)

    Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

    Time frame: 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)

    Time frame: Up to 20 Days

07

Results

Posted Jul 9, 2026

Participant flow

Participants were recruited at 3 investigational sites. The first participant enrolled was on 20-Feb-2025 and the last participant was enrolled on 15-Jul-2025.

Participant flow — Overall Study
MilestoneSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Started6600
Completed6500
Not completed0100
Withdrew: Withdrawal by subject0100

Outcome measures

PrimaryArea Under the Concentration Time Curve [AUC]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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
Reported as:
Geometric mean · ng.h/mL
Area Under the Concentration Time Curve [AUC]
ng.h/mLSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - AUC0-12 Day 127000 ± 71.614300 ± 34.4——
Total ALG-097558 - AUC0-12 Day 621100 ± 53.014300 ± 35.5——
Unbound ALG-097558 - AUC0-12 Day 11070 ± 74.7561 ± 58.0——
Unbound ALG-097558 - AUC0-12 Day 6857 ± 50.1694 ± 25.8——
Total ALG-097730 - AUC0-12 Day 16040 ± 65.73260 ± 28.4——
Total ALG-097730 - AUC0-12 Day 65650 ± 62.33490 ± 28.2——
Unbound ALG-097730 - AUC0-12 Day 11130 ± 73.0630 ± 54.2——
Unbound ALG-097730 - AUC0-12 Day 6992 ± 67.1620 ± 43.3——
Total ALG-097558 - AUC0-last Day 623900 ± 54.515700 ± 35.5——
Unbound ALG-097558 - AUC0-last Day 6867 ± 50.3568 ± 39.7——
Total ALG-097730 - AUC0-last Day 67400 ± 70.34300 ± 24.5——
Unbound ALG-097730 - AUC0-last Day 61020 ± 68.8620 ± 42.9——
PrimaryMaximum Plasma Concentration [Cmax]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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
Reported as:
Geometric mean · ng/mL
Maximum Plasma Concentration [Cmax]
ng/mLSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - Cmax Day 15260 ± 55.83500 ± 35.7——
Total ALG-097558 - Cmax Day 63870 ± 38.63040 ± 45.0——
Unbound ALG-097558 - Cmax Day 1252 ± 58.3182 ± 50.9——
Unbound ALG-097558 - Cmax Day 6178 ± 44.7147 ± 47.7——
Total ALG-097730 - Cmax Day 1893 ± 45.8611 ± 31.9——
Total ALG-097730 - Cmax Day 6853 ± 46.5584 ± 36.8——
Unbound ALG-097730 - Cmax Day 1194 ± 49.1144 ± 49.8——
Unbound ALG-097730 - Cmax Day 6179 ± 47.1123 ± 59.9——
PrimaryMinimum Plasma Concentration [Cmin]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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
Reported as:
Geometric mean · ng/mL
Minimum Plasma Concentration [Cmin]
ng/mLSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - Cmin Day 6326 ± 108160 ± 38.0——
Total ALG-097730 - Cmin Day 6154 ± 10075.0 ± 35.5——
PrimaryC0 [Predose]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Time frame:
Pre-dose (-0.75 hours) up to Day 8
Reported as:
Geometric mean · ng/mL
C0 [Predose]
ng/mLSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - Ctrough Day 2509 ± 122226 ± 30.7——
Total ALG-097558 - Ctrough Day 3464 ± 59.5323 ± 44.3——
Total ALG-097558 - Ctrough Day 4542 ± 89.4372 ± 46.4——
Total ALG-097558 - Ctrough Day 5424 ± 67.5295 ± 108——
Total ALG-097558 - Ctrough Day 6623 ± 66.6321 ± 58.3——
Unbound ALG-097558 - Ctrough Day 229.4 ± 69.7NA——
Unbound ALG-097558 - Ctrough Day 315.0 ± 67.011.7 ± 4.55——
Unbound ALG-097558 - Ctrough Day 420.9 ± 61.613.5 ± 14.3——
Unbound ALG-097558 - Ctrough Day 514.8 ± 72.214.8 ± 35.9——
Unbound ALG-097558 - Ctrough Day 619.1 ± 68.113.7 ± 44.2——
Total ALG-097730 - Ctrough Day 2218 ± 129100 ± 25.3——
Total ALG-097730 - Ctrough Day 3205 ± 71.2119 ± 38.4——
Total ALG-097730 - Ctrough Day 4226 ± 89.1135 ± 33.9——
Total ALG-097730 - Ctrough Day 5198 ± 84.1114 ± 66.7——
Total ALG-097730 - Ctrough Day 6249 ± 75.6120 ± 44.2——
Unbound ALG-097730 - Ctrough Day 228.1 ± 14913.7 ± 48.9——
Unbound ALG-097730 - Ctrough Day 328.3 ± 10116.7 ± 18.5——
Unbound ALG-097730 - Ctrough Day 429.3 ± 10318.8 ± 30.8——
Unbound ALG-097730 - Ctrough Day 526.0 ± 10217.1 ± 56.2——
Unbound ALG-097730 - Ctrough Day 637.7 ± 85.018.2 ± 57.0——
PrimaryHalf-life [t1/2]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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
Reported as:
Geometric mean · hours
Half-life [t1/2]
hoursSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - t1/2 Day 68.80 ± 32.37.29 ± 39.0——
Total ALG-097730 - t1/2 Day 611.4 ± 40.511.6 ± 48.3——
PrimaryTime to Maximum Plasma Concentration [Tmax]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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
Reported as:
Median · hours
Time to Maximum Plasma Concentration [Tmax]
hoursSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - Tmax Day 12.00 (1.92 to 3.67)2.02 (2.00 to 3.00)——
Total ALG-097558 - Tmax Day 63.00 (2.00 to 4.05)2.50 (1.00 to 6.00)——
Total ALG-097730 - Tmax Day 13.83 (2.00 to 6.00)3.00 (2.00 to 3.00)——
Total ALG-097730 - Tmax Day 63.49 (3.00 to 8.02)2.00 (1.00 to 3.02)——
PrimaryApparent Clearance (CL/F)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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
Reported as:
Geometric mean · L/h
Apparent Clearance (CL/F)
L/hSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - CL/F Day 614.3 ± 53.021.0 ± 35.5——
Unbound ALG-097558 - CL/F Day 6350 ± 50.1432 ± 25.8——
PrimaryApparent Volume of Distribution (V/F)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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
Reported as:
Geometric mean · L
Apparent Volume of Distribution (V/F)
LSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - Vz/F Day 6181 ± 68.1220 ± 49.1——
Unbound ALG-097558 - Vz/F Day 61300 ± 97.31450 ± 21.6——
PrimaryTotal Amount of Drug Excreted in Urine (Ae)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

Time frame:
Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose
Reported as:
Mean · mg
Total Amount of Drug Excreted in Urine (Ae)
mgSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - Ae 0-6 Day 12.10 ± 0.73610.8 ± 5.86——
Total ALG-097558 - Ae 6-12 Day 10.979 ± 0.6651.24 ± 1.37——
Total ALG-097558 - Ae 0-12 Day 13.08 ± 1.2312.1 ± 6.61——
Total ALG-097558 - Ae 0-6 Day 61.46 ± 0.7508.03 ± 5.95——
Total ALG-097558 - Ae 6-12 Day 60.708 ± 0.6001.04 ± 0.641——
Total ALG-097558 - Ae 12-24 Day 60.182 ± 0.1570.249 ± 0.0620——
Total ALG-097558 - Ae 24-36 Day 60.0348 ± 0.01680.0817 ± 0.0446——
Total ALG-097558 - Ae 36-48 Day 60.0113 ± 0.005260.0386 ± 0.0284——
Total ALG-097558 - Ae 0-12 Day 62.16 ± 0.9169.06 ± 6.54——
Total ALG-097558 - Ae 0-24 Day 62.35 ± 0.9669.31 ± 6.56——
Total ALG-097558 - Ae 0-36 Day 62.38 ± 0.9739.39 ± 6.57——
Total ALG-097558 - Ae 0-48 Day 62.39 ± 0.9759.43 ± 6.56——
Total ALG-097730 - Ae 0-6 Day 10.615 ± 0.1743.44 ± 1.69——
Total ALG-097730 - Ae 6-12 Day 10.479 ± 0.2990.701 ± 0.676——
Total ALG-097730 - Ae 0-12 Day 11.09 ± 0.2744.14 ± 2.00——
Total ALG-097730 - Ae 0-6 Day 60.651 ± 0.3232.81 ± 1.65——
Total ALG-097730 - Ae 6-12 Day 60.467 ± 0.4690.733 ± 0.452——
Total ALG-097730 - Ae 12-24 Day 60.181 ± 0.2200.260 ± 0.0772——
Total ALG-097730 - Ae 24-36 Day 60.0602 ± 0.06190.109 ± 0.0369——
Total ALG-097730 - Ae 36-48 Day 60.0255 ± 0.02030.0660 ± 0.0494——
Total ALG-097730 - Ae 0-12 Day 61.12 ± 0.6773.54 ± 2.08——
Total ALG-097730 - Ae 0-24 Day 61.30 ± 0.8583.80 ± 2.13——
Total ALG-097730 - Ae 0-36 Day 61.36 ± 0.9173.91 ± 2.16——
Total ALG-097730 - Ae 0-48 Day 61.38 ± 0.9333.98 ± 2.14——
PrimaryRenal Clearance (CLr)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

Time frame:
Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose.
Reported as:
Mean · L/h
Renal Clearance (CLr)
L/hSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Total ALG-097558 - CLr Day 60.102 ± 0.04470.666 ± 0.539——
Total ALG-097730 - CLr Day 60.181 ± 0.07531.04 ± 0.694——
SecondaryIncidence 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)

Time frame:
Up to 20 Days
Reported as:
Number · Number of participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participantsSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
Any TEAE11——
Any treatment-related TEAE10——
Any grade ≥3 TEAE00——
Any treatment-related grade ≥3 TEAE00——
Any SAE00——
Any treatment-related SAE00——
Any TEAE leading to early discontinuation00——
Any death00——

Adverse events

Collected over Up to 20 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Subjects With Severe Renal Impairment0/6 (0%)0/6 (0%)1/6 (16.7%)
Subjects With Normal Renal Function0/6 (0%)0/6 (0%)1/6 (16.7%)
Subjects With Mild Renal Impairment (Optional)———
Subjects With Moderate Renal Impairment (Optional)———
Most frequent other events
Most frequent other events
EventSubjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)
NauseaGastrointestinal disorders1/60/6——
Upper respiratory tract infectionInfections and infestations0/61/6——

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
Mean53.3 ± 14.0147.3 ± 6.38——50.3 ± 10.84
Sex: Female, Male
Sex: Female, Male(Participants)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
Female11002
Male550010
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American32005
White34007
More than one race00000
Unknown or Not Reported00000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
Hispanic or Latino54009
Not Hispanic or Latino12003
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
United States66——12
Height
Height(centimetres)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
Mean171.18 ± 9.839175.62 ± 7.612——173.40 ± 8.701
Weight
Weight(kg)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
Mean80.47 ± 23.58477.08 ± 7.184——78.78 ± 16.715
Body Mass Index
Body Mass Index(kg/m^2)Subjects With Severe Renal ImpairmentSubjects With Normal Renal FunctionSubjects With Mild Renal Impairment (Optional)Subjects With Moderate Renal Impairment (Optional)Total
Mean27.20 ± 6.07324.95 ± 0.517——26.08 ± 4.274

2 further baseline measures are reported on the registry.

08

Study locations

3 sites
  • University of Miami
    Miami, Florida 33136, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • Genesis Clinical Trials
    Tampa, Florida 33603, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06698549
Lead sponsor
Aligos Therapeutics
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Feb 20, 2025
Primary completion
Jul 23, 2025
Completion
Aug 13, 2025
Results posted
Jul 9, 2026
Last update
Aug 25, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: ALG-097558

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