A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations

NCT06959888 | Completed Phase 1 FDA Drug

• 1 other identifier: ALG-055009-304
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 single dose, open-label, randomized, two-period, two-sequence, crossover study of ALG-055009 conducted in 1 cohort of healthy volunteers. The primary purpose of this study is to compare the single-dose pharmacokinetics of the 0.7 mg dose level of 2 types of soft gelatin capsule formulations of ALG-055009, Formulation 1 and Formulation 2, in approximately 8 healthy volunteers.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (8)

• AUC0-24 of ALG-055009 in Plasma

  AUC0-24, of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

• AUClast of ALG-055009 in Plasma

  AUClast of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

• AUCinf of ALG-055009 in Plasma

  AUCinf of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

• Tmax of ALG-055009 in Plasma

  Tmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

• Cmax of ALG-055009 in Plasma

  Cmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

• C24 of ALG-055009 in Plasma

  C24 of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

• C0 (predose) of ALG-055009 in Plasma

  C0 (predose) of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

• t½ of ALG-055009 in Plasma

  t½ of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2

  12 days

Secondary Outcomes (1)

• Safety Data

  22 days

Study Arms (2)

Sequence A

EXPERIMENTAL

Single dose PO administration of 0.7 mg ALG-055009 (Formulation 1; Day 1), then a washout period of at least 7 days, followed by single dose PO administration of 0.7 mg ALG-055009 (Formulation 2; Day 8)

Drug: ALG-055009

Sequence B

EXPERIMENTAL

Single dose PO administration of 0.7 mg ALG-055009 (Formulation 2; Day 1), then a washout period of at least 7 days, followed by single dose PO administration of 0.7 mg ALG-055009 (Formulation 1; Day 8)

Drug: ALG-055009

Interventions

ALG-055009 DRUG

Single PO dose of 0.7 mg ALG-055009 softgel capsule (formulation 1) Single PO dose of 0.7 mg ALG-055009 softgel capsule (formulation 2)

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must sign an informed consent form (ICF) indicating that he or she understands that risks of purpose of and procedures required for, the study and is willing to participate in the study.
• In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
• Male or female between 18 and 65 years of age, extremes included.
• Subjects must have a bod mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.
• Female subjects must be either:
• Post menopausal: A postmenopausal state is defined as no menses for at least 12 months without an alternative medical explanation . A high follicle-stimulating hormone (FSH) level in the postmenopausal range of \>40 IU may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT).
• Permanently Sterile : Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
• Woman of Childbearing Potential: They are only eligible if they and any non-sterile male sexual partners agree to use highly effective contraceptive therapy from the screening visit until at least 60 days after the last dose of study drug
• Female subjects must have a negative pregnancy test at screening and Day-1.
• Female subjects must not be pregnant, or breastfeeding, or planning to become pregnant or donate eggs from screening onward until 60 days after the last dose of study drug (or longer if dictated by local regulation).
• Male subjects must agree to wear a condom during sexual intercourse and their female sexual partners should agree to use effective means of contraception. These contraceptive measures must be implemented, at a minimum, from the start of dosing until at least 90 days after the last dose.
• Male subjects must have no plans to father a child or donate sperm while enrolled in this study or within 90 days after the last dose of study drug.
• Heart rate between 40 and 100 beats per minute (bpm), extremes included;
• QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) ≤450 ms (males) or ≤470 ms (females);
• QRS interval ≤120 ms;

You may not qualify if:

• Any potential subject who meets any of the following criteria will be excluded from participating in the study.
• 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' interpretation. This may include, but is not limited to renal, cardiac, vascular, pulmonary, gastrointestinal, hepatologic, endocrine, neurologic, dermatologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
• Subjects with medical history or current evidence of a pituitary disorder or thyroid disorder.
• Subjects with thyroid-stimulating hormone (TSH), free thyroxine (T4) or total triiodothyronine
• Subjects with known sensitivity to thyroid medications
• ALT or AST \> ULN
• Total bilirubin \> 1.2xULN, unless Gilbert's syndrome is suspected
• 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 or unstable cardiac disease, such as: angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia.
• History of unexplained syncope.
• Subjects with current:
• Hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]).
• Hepatitis B infection defined as presence of HBsAg or HBV core antibody.
• Hepatitis C virus (HCV) infection (confirmed by HCV antibody and/or HCV RNA). Subjects who have been treated and achieved sustained virologic response ≥6 months prior to screening with HCV RNA \<LLOQ, target not detected, remain eligible.
• Human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening.
• Acute infection at the time of enrollment. If an acute infection is considered resolved prior to enrollment, the subject remains eligible.

Sponsors & Collaborators

• Aligos Therapeutics: lead

Study Sites (1)

PPD Austin CRU

Austin, Texas, 78744, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: May 7, 2025
• Study Start: March 25, 2025
• Primary Completion: May 8, 2025
• Study Completion: May 16, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

US (1)