HIV InfectionsPhase 1NCT06012136
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
A Phase 1 study testing VH4004280 and VH4011499 in people with HIV Infections, run by ViiV Healthcare at 2 sites in United States.
Trial summary
The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4004280 and VH4011499
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2023to 9 Jun 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy.
- Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1.
- Male or female participants of non-childbearing potential.
- Capable of giving signed informed consent.
Who cannot join
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Abnormal blood pressure.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation.
Show all 20Show fewer
- The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites.
- Participants considered to have insufficient musculature to allow safe capsid inhibitor intramuscular (gluteus medius) administration.
- History of or on-going high-risk behaviours that may put the participant at increased risk for HIV.
- Past or intended use of over-the-counter or prescription medication including herbal medications.
- Current enrollment or recent past participation in another investigational study.
- Exposure to more than 4 investigational products within 12 months prior to dosing.
- Alanine transaminase (ALT) ≥1.5x upper limit of normal (ULN), Total bilirubin ≥1.5x ULN (isolated total bilirubin >1.5xULN), and/or estimated creatinine clearance (eGFR) of <60 millilitre per minute (mL/min)/1.73 square meter (m^2).
- History of or current infection with hepatitis B or hepatitis C.
- Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms, or having contact with known coronavirus disease 2019 (COVID-19) positive person/s in the 14 days prior to inpatient admission.
- Use of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse.
- Positive HIV antibody/antigen test.
- Abnormal electrocardiogram (ECG) parameters.
- Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (>3 seconds).
- The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers (gluteal) which may interfere with interpretation of injection site reactions or administration of study product.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Austin, Texas, 78744
GSK Investigational Site
Las Vegas, Nevada, 89113
About this study
Official title: A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Parenterally Administered Suspension of Investigational Capsid Inhibitors in Healthy Adults
The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.
- Conditions
- HIV Infections
- Being tested
- VH4004280, Placebo, VH4011499
- Keywords
- Healthy participants, Human Immunodeficiency Virus (HIV-1), VH4004280, VH4011499, Long-Acting Injection, Single ascending dose
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4004280Drug
VH4004280 will be administered.
PlaceboDrug
Placebo will be administered.
VH4011499Drug
VH4011499 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Single Ascending Dose (SAD): Participants Receiving VH4004280 | Experimental | VH4004280 injections are administered subcutaneously (SC), SC+ rHuPH20, or intramuscularly (IM). Receives: Drug: VH4004280 |
| Part 1: Participants Receiving Placebo | Placebo comparator | Placebo injection is administered. Receives: Drug: Placebo |
| Part 2 SAD: Participants Receiving VH4011499 | Experimental | VH4011499 injections are administered SC, SC+ rHuPH20, or IM. Receives: Drug: VH4011499 |
| Part 2 Multiple Ascending Dose (MAD): Participants Receiving VH4011499 | Experimental | VH4011499 injections are administered IM. Receives: Drug: VH4011499 |
| Part 2: Participants Receiving Placebo | Placebo comparator | Placebo injection is administered. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD: Number of Participants with Adverse Events (AEs) as per Severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
Measured: Up to Week 52
MAD: Number of Participants with Adverse Events (AEs) as per Severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
Measured: Up to Week 56
SAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
Measured: Up to Week 52
MAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
Measured: Up to Week 56
SAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)
Measured: Baseline (Prior to Day 1) and up to Week 52
MAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)
Measured: Baseline (Prior to Day 1) and up to Week 56
SAD: Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)
Measured: Up to Week 52
MAD: Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)
Measured: Up to Week 56
SAD: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)
Measured: Up to Week 52
MAD: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)
Measured: Up to Week 56
SAD: Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter)
Measured: Baseline (Prior to Day 1) and up to Week 52
MAD: Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter)
Measured: Baseline (Prior to Day 1) and up to Week 56
SAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale
DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
Measured: Up to Week 52
MAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale
DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
Measured: Up to Week 56
SAD: Duration of ISR (Days) AE
Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.
Measured: Up to Week 52
MAD: Duration of ISR (Days) AE
Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.
Measured: Up to Week 56
Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4004280
Measured: Up to Week 52
Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4011499
Measured: Up to Week 56
Maximum Observed Plasma Concentration (Cmax) of VH4004280
Measured: Up to Week 52
Maximum Observed Plasma Concentration (Cmax) of VH4011499
Measured: Up to Week 56
Time of Maximum Observed Plasma Concentration (tmax) of VH4004280
Measured: Up to Week 52
Time of Maximum Observed Plasma Concentration (tmax) of VH4011499
Measured: Up to Week 56
Apparent Terminal Half-life (t1/2) of VH4004280
Measured: Up to Week 52
Apparent Terminal Half-life (t1/2) of VH4011499
Measured: Up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start24 Aug 2023
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012136
- Sponsor's protocol ID
- 218306
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Parenterally Administered Suspension of Investigational Capsid Inhibitors in Healthy Adults
- ClinicalTrials.gov ID
- NCT06012136
- Acronym / sponsor ID
- 218306
- Conditions
- HIV Infections
- Keywords
- Healthy participants, Human Immunodeficiency Virus (HIV-1), VH4004280, VH4011499, Long-Acting Injection, Single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 25 Aug 2023 (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.
The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Ascending Dose (SAD): Participants Receiving VH4004280 | Experimental | Drug: VH4004280VH4004280 injections are administered subcutaneously (SC), SC+ rHuPH20, or intramuscularly (IM). |
| Part 1: Participants Receiving Placebo | Placebo comparator | Drug: PlaceboPlacebo injection is administered. |
| Part 2 SAD: Participants Receiving VH4011499 | Experimental | Drug: VH4011499VH4011499 injections are administered SC, SC+ rHuPH20, or IM. |
| Part 2 Multiple Ascending Dose (MAD): Participants Receiving VH4011499 | Experimental | Drug: VH4011499VH4011499 injections are administered IM. |
| Part 2: Participants Receiving Placebo | Placebo comparator | Drug: PlaceboPlacebo injection is administered. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who are overtly healthy.
- Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1.
- Male or female participants of non-childbearing potential.
- Capable of giving signed informed consent.
Key exclusion criteria (20 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Abnormal blood pressure.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
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 |
|---|---|---|
| VH4004280VH4004280 will be administered. | Drug | Part 1 Single Ascending Dose (SAD): Participants Receiving VH4004280 |
| PlaceboPlacebo will be administered. | Drug | Part 1: Participants Receiving Placebo, Part 2: Participants Receiving Placebo |
| VH4011499VH4011499 will be administered. | Drug | Part 2 Multiple Ascending Dose (MAD): Participants Receiving VH4011499, Part 2 SAD: Participants Receiving VH4011499 |
Primary outcome
SAD: Number of Participants with Adverse Events (AEs) as per Severity
Time frame: Up to Week 52
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
MAD: Number of Participants with Adverse Events (AEs) as per Severity
Time frame: Up to Week 56
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
SAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
Time frame: Up to Week 52
MAD: Absolute Values of Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (micromoles per liter [umol/L])
Time frame: Up to Week 56
SAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)
Time frame: Baseline (Prior to Day 1) and up to Week 52
MAD: Change from Baseline in Liver Chemistry Parameters: Total Bilirubin and Direct Bilirubin (umol/L)
Time frame: Baseline (Prior to Day 1) and up to Week 56
SAD: Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)
Time frame: Up to Week 52
MAD: Number of Participants with Maximum Toxicity Grade Change from Baseline in Liver Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)
Time frame: Up to Week 56
SAD: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)
Time frame: Up to Week 52
MAD: Absolute Values of Liver Chemistry Parameters: Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) (International Units per liter)
Time frame: Up to Week 56
SAD: Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter)
Time frame: Baseline (Prior to Day 1) and up to Week 52
MAD: Change from Baseline in Liver Chemistry Parameters: Alkaline Phosphatase, AST, and ALT (International Units per liter)
Time frame: Baseline (Prior to Day 1) and up to Week 56
SAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale
Time frame: Up to Week 52
DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
MAD: Number of Participants with Injection Site Reactions (ISR) AE by Grade Using the DAIDS Grading Scale
Time frame: Up to Week 56
DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from grade 1(lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.
SAD: Duration of ISR (Days) AE
Time frame: Up to Week 52
Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.
MAD: Duration of ISR (Days) AE
Time frame: Up to Week 56
Duration of ISR will be assessed as the time up to which a reaction related to injection site event is persistent.
Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4004280
Time frame: Up to Week 52
Area Under the Plasma-concentration Time curve from Time Zero to Infinity (AUC0-inf) of VH4011499
Time frame: Up to Week 56
Maximum Observed Plasma Concentration (Cmax) of VH4004280
Time frame: Up to Week 52
Maximum Observed Plasma Concentration (Cmax) of VH4011499
Time frame: Up to Week 56
Time of Maximum Observed Plasma Concentration (tmax) of VH4004280
Time frame: Up to Week 52
Time of Maximum Observed Plasma Concentration (tmax) of VH4011499
Time frame: Up to Week 56
Apparent Terminal Half-life (t1/2) of VH4004280
Time frame: Up to Week 52
Apparent Terminal Half-life (t1/2) of VH4011499
Time frame: Up to Week 56
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 5 Aug 2026.
- Individual participant dataSharing planned: Yes. Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf.
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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.
2 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 VH4004280 and VH4011499 in people with HIV Infections, run by ViiV Healthcare at 2 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 4 inclusion and 20 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 5 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 2 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. Some participants in this study may receive a placebo. 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?
SAD: Number of Participants with Adverse Events (AEs) as per Severity (time frame: Up to Week 52). The study lists 24 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 5 Aug 2026.