Healthy Volunteer StudyPhase 1NCT06959888
A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations
A Phase 1 study testing ALG-055009 in people with Healthy Volunteer Study, run by Aligos Therapeutics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- ALG-055009
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to 16 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- OR
- Permanently Sterile : Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- OR
- 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.
- Subjects must have a 12-lead ECG that meets the following inclusion criteria
- 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;
- PR interval ≤110 to ≤220 ms;
- In addition to fulfilling the above ECG criteria, ECG morphology must have no clinically significant abnormalities observed in the opinion of the Investigator.
- Subjects must be deemed to be in good overall health by the investigator on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs, and the results of blood chemistry, blood coagulation and hematology tests, and a urinalysis performed at screening.
- Subjects must be willing and able to adhere to the prior and concomitant medications requirements
Who cannot join
- 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
- The laboratory values at screening are exclusionary:
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- 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.
- Subjects who had major surgery (e.g., requiring general anesthesia) within 12 weeks before randomization, or will not have fully recovered from surgery, or have surgery planned during the time the subjects is expected to participate in the study, or within 4 weeks after the last dose of study drug
- Subjects with a recent (within 1 year of randomization/enrollment) history of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use. Use of these drugs under physician supervision (e.g., prescription narcotics for known pain disorder) are not exclusionary. Cannabis use within 4 weeks of screening and during the study is exclusionary.
- Excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/week for men (Chalasani et al. 2018). For current definition of a standard drink, please refer to the National Institute on Alcohol Abuse and Alcoholism website (https://www.niaaa.nih.gov/what-standard-drink).
- Unwilling to abstain from alcohol use for 48 hours prior to Day -1 through end of study follow up.
- Positive results for urine drug screen or alcohol test at screening or Day -1.
- Any laboratory result considered clinically significant by the Investigator at screening. Values of ALT and AST >ULN, and total bilirubin >1.2×ULN (see Exclusion Criteria 6), and values of TSH, free T4, and total T3 >1.1×ULN and <0.9×LLN (see Exclusion Criteria 4) are exclusionary regardless of any clinical significance assessment by the Investigator.
- Clinically significant abnormal vital signs (evaluated in the semi-recumbent [i.e., elevation of the head-to-bed at 30-45 degrees] or supine position after 5 minutes of rest), confirmed with retesting after at least 5 minutes of additional rest. Vital sign reference ranges to assess eligibility are as follows:
- Systolic blood pressure: ≥90 to ≤140 mmHg
- Diastolic blood pressure: ≥40 to ≤90 mmHg
- Pulse rate: ≥40 to ≤100 beats per minute
- Physical examination findings that are considered clinically significant and likely to adversely impact study conduct and/or interpretation are exclusionary.
- Renal dysfunction [e.g., estimated creatinine clearance <90 mL/min/1.73 m2 at screening, calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (without correction for African ancestry)].
- History of clinically significant drug allergy such as, but not limited to, sulfonamides or drug allergy witnessed in previous studies with experimental drugs.
- Has taken or requires treatment with: any therapies as noted in Prior and Concomitant Medications (Section 6.10) and Special Precautions (Section 6.11) within 1 week or 5 half-lives (whichever is longer) before the planned first dose of study drug or during dosing; any Prohibited Medications (Appendix B) within 28 days or 5 half-lives (whichever is longer) before the planned first dose of study drug or during dosing.
- Consumption of grapefruit, grapefruit juice, and Seville oranges within 14 days prior to study drug administration.
- Consumption of apple or orange juice, citrus fruits, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats within 7 days prior to study drug administration.
- Consumption of any food or drink/beverage containing quinine (e.g., tonic, bitter lemon, bitter alcoholic beverages containing quinine) within 24 hours prior to study drug administration.
- Received an unapproved investigational agent within 4 weeks (or 5 half-lives, whichever is longer) prior to enrollment.
- Currently participating in another clinical or medical interventional research study.
- Employee of the Sponsor, the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ALG-055009
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALG-055009Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: ALG-055009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 days
Secondary outcomes (1)
Safety Data
The number and severity of treatment emergent adverse events as assessed by CTCAE v5.0
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start25 Mar 2025
- Primary completion8 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959888
- Sponsor's protocol ID
- ALG-055009-304
- Status last verified
- Jul 2025
- First submitted
- 24 Mar 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of ALG-055009 Formulations
- ClinicalTrials.gov ID
- NCT06959888
- Acronym / sponsor ID
- ALG-055009-304
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: ALG-055009Single 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) |
| Sequence B | Experimental | Drug: ALG-055009Single 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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:
Key exclusion criteria (36 listed)
- 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
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-055009Single 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) | Drug | Sequence A, Sequence B |
Primary outcome
AUC0-24 of ALG-055009 in Plasma
Time frame: 12 days
AUC0-24, of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
AUClast of ALG-055009 in Plasma
Time frame: 12 days
AUClast of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
AUCinf of ALG-055009 in Plasma
Time frame: 12 days
AUCinf of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
Tmax of ALG-055009 in Plasma
Time frame: 12 days
Tmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
Cmax of ALG-055009 in Plasma
Time frame: 12 days
Cmax of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
C24 of ALG-055009 in Plasma
Time frame: 12 days
C24 of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
C0 (predose) of ALG-055009 in Plasma
Time frame: 12 days
C0 (predose) of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
t½ of ALG-055009 in Plasma
Time frame: 12 days
t½ of ALG-055009 in plasma following single dose administration of 0.7 mg ALG-055009 Formulation 1 and Formulation 2
1 secondary outcome
Safety Data
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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.
1 site 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-055009 in people with Healthy Volunteer Study, run by Aligos Therapeutics at 1 site 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 22 inclusion and 36 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC0-24 of ALG-055009 in Plasma (time frame: 12 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2025.