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New treatment option for Healthy Participants
Official title A First-In-Human Study of ARO-033 in Adult Participants
ClinicalTrials.gov ID: NCT07662096
What this study is testing
What is ARO-033?
ARO-033 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy participants.
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
- This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-033 compared to placebo in adult normal healthy volunteers (NHVs).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 65. Healthy volunteers may be eligible.
You may be able to join if
- Adults who are not pregnant, not breastfeeding, and do not plan to become pregnant (or impregnate their partners) during the study and for at least...
- Body mass index (BMI) between 18.0 and 35.0 kilograms (kg)/square meter (m\^2), inclusive.
- No abnormal finding of clinical relevance at the Screening evaluation that in the opinion of the Investigator could adversely impact participant's...
You likely can't join if
- Human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV antibody (seropositive).
- Seropositive for hepatitis B virus (HBV) (hepatitis B surface antigen positive at screening) or hepatitis C virus (HCV) (HCV antibody positive with...
- Uncontrolled hypertension (resting systolic blood pressure ≥160 millimeters of mercury [mmHg] or diastolic blood pressure ≥95 mmHg, confirmed by...
- Evidence of clinically significant immunocompromising condition (for example, primary immunodeficiency syndrome, aplastic anemia, known or suspected...
- History of major surgery within 90 days of Screening.
- Use of an investigational agent or device within 30 days or 5 half-lives (whichever is longer) prior to dosing or current participation in an...
See the full eligibility criteria
- Adults who are not pregnant, not breastfeeding, and do not plan to become pregnant (or impregnate their partners) during the study and for at least 90 days following the end of the study.
- Body mass index (BMI) between 18.0 and 35.0 kilograms (kg)/square meter (m\^2), inclusive.
- No abnormal finding of clinical relevance at the Screening evaluation that in the opinion of the Investigator could adversely impact participant's safety during the study or adversely impact study results. Key
- Human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV antibody (seropositive).
- Seropositive for hepatitis B virus (HBV) (hepatitis B surface antigen positive at screening) or hepatitis C virus (HCV) (HCV antibody positive with reflex confirmation using HCV RNA amplification at Screening). Cured...
- Uncontrolled hypertension (resting systolic blood pressure ≥160 millimeters of mercury [mmHg] or diastolic blood pressure ≥95 mmHg, confirmed by repeat measurement, at Screening).
- Evidence of clinically significant immunocompromising condition (for example, primary immunodeficiency syndrome, aplastic anemia, known or suspected complement factor deficiency, or any other condition resulting in...
- History of major surgery within 90 days of Screening.
- Use of an investigational agent or device within 30 days or 5 half-lives (whichever is longer) prior to dosing or current participation in an investigational study. Participants recently participating in studies...
- Any medical condition or clinically significant laboratory abnormality at Screening that in the opinion of the Investigator should exclude the participant from participation, preclude safe and successful completion of...
The study team makes the final eligibility decision.
Where it's taking place
- Auckland, New Zealand
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 - 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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.