Trial studying safety and effects for HIV Infections
Official title A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT05418868
What this study is testing
What is Cabotegravir 200 mg/mL?
This is an investigational injectable medicine being studied for HIV infections. It is designed to block an enzyme called integrase that the HIV virus needs to copy its genetic material and infect new cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at the safety, how the drug stays in the body, and how well it works when given once or repeatedly under the skin or in the muscle.
- Who it's for
- Healthy adults who do not have HIV.
- What's involved
- Participants receive a single or repeated injection of the drug, sometimes with a special enzyme, and will have blood tests and medical check‑ups to monitor safety and drug levels.
- Time commitment
- The study lasts several weeks to months, with multiple clinic visits for injections and blood draws, depending on the part of the study you join.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- At the time of obtaining informed consent, participants age should be greater than or equal to (\>=)18 years and less than or equal to (\<=) 55 years.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and...
- Body weight \>=40 kilogram (kg) and body mass index (BMI) within the range \>=18 to \<=32 kilogram per meter square (kg/m\^2).
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in...
- Capable of giving written informed consent.
You likely can't join if
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for...
- Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.
- History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection...
- Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of...
See the full eligibility criteria
- At the time of obtaining informed consent, participants age should be greater than or equal to (\>=)18 years and less than or equal to (\<=) 55 years.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body weight \>=40 kilogram (kg) and body mass index (BMI) within the range \>=18 to \<=32 kilogram per meter square (kg/m\^2).
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving written informed consent.
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.
- Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.
- History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant...
- Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
- Abnormal blood pressure.
- Evidence of previous myocardial infarction.
- Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [2nd degree or higher], Wolff- Parkinson-White [WPW] syndrome).
- Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant.
- One or more exclusionary values for a screening Electrocardiogram (ECG).
- Alanine transaminase (ALT) \>upper limit of normal (ULN). - Bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent [%]).
- Estimated Glomerular Filtration Rate (eGFR) \<60 milliliter per minute (mL/min) using the Chronic Kidney Disease - Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021).
- Hemoglobin \<12.5 gram per deciliter (g/dL) for men and \<11 g/dL for women.
- Positive pre-study drug/alcohol screen.
- Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g...
- Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of \>14 units for males or \>7 units for females.
- Regular use of known drugs of abuse.
- Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day...
- Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
- Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day.
- History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their...
- Current or anticipated need for chronic anti-coagulation therapy.
- Hereditary coagulation and platelet disorders (e.g., hemophilia or Von Willebrand disease [VWD]).
- Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria)...
- Any other clinical condition, behavior or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements
- Participant who in the investigator's judgment poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
- Fasting glucose \>125 mg/dL (6.95 mmol/L; Grade \>2) or in treatment for elevated blood glucose.
- Triglycerides \>500 mg/dL (5.7 mmol/L; Grade \>3) or in treatment for dyslipidemia.
The study team makes the final eligibility decision.
Where it is enrolling
- Las Vegas, Nevada, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Las Vegas, Nevada, United States; Austin, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.