BridgeMD
Tests treatment safety and results for Healthy
Official title A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
ClinicalTrials.gov ID: NCT06995820
What this study is testing
What is AZD1613?
AZD1613 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy.
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 purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy participants, including Japanese and Chinese descent.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture.
- Negative pregnancy test at screening and admission (females only).
- Females of non-childbearing potential confirmed by postmenopausal status or irreversible surgical sterilization.
- Sexually active fertile males must use contraception methods from first administration until 3 months after the last follow-up visit.
- Body mass index (BMI) between 18 and 32 kg/m² and weight at least 50 kg.
You likely can't join if
- The history of any clinically important disease or disorder may either put the participant at risk due to participation in the study, influence the...
- History or presence of gastrointestinal, hepatic, or renal disease affecting drug absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of first administration.
- Abnormal lab values at screening or admission (e.g., alanine aminotransferase (ALT) \> upper limit normal (ULN), aspartate aminotransferase (AST) \>...
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
- Any positive result for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab) or Human...
See the full eligibility criteria
- Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture.
- Negative pregnancy test at screening and admission (females only).
- Females of non-childbearing potential confirmed by postmenopausal status or irreversible surgical sterilization.
- Sexually active fertile males must use contraception methods from first administration until 3 months after the last follow-up visit.
- Body mass index (BMI) between 18 and 32 kg/m² and weight at least 50 kg.
- Participants of Chinese descent (Part A2) must have both parents and four grandparents who are Chinese.
- Participants of Japanese descent (Part A3) must have both parents and four grandparents who are Japanese.
- The history of any clinically important disease or disorder may either put the participant at risk due to participation in the study, influence the results, or affect the participant's ability to participate in the...
- History or presence of gastrointestinal, hepatic, or renal disease affecting drug absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of first administration.
- Abnormal lab values at screening or admission (e.g., alanine aminotransferase (ALT) \> upper limit normal (ULN), aspartate aminotransferase (AST) \> ULN, bilirubin \> 1.5 × ULN, estimated glomerular filtration rate...
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
- Any positive result for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab) or Human immunodeficiency virus (HIV).
- Abnormal vital signs after 5 minutes supine rest at screening or admission (e.g., systolic BP \ 85 bpm).
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting 12-lead Electrocardiogram (ECG) at screening or admission (e.g., prolonged QTcF \> 450 ms, shortened QTcF \< 340 ms, family history...
- Smokers who smoke more than 5 cigarettes per day and cannot adhere to no smoking during residential visits.
- Known or suspected history of alcohol or drug abuse or excessive alcohol intake.
- Positive screen for drugs of abuse or alcohol at screening or admission.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Use of prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, or intake of \> 3 × daily recommended levels of vitamins and minerals during the 2...
- Plasma donation within one month of screening or any blood donation/blood loss \> 500 mL during the 3 months prior to screening.
- Received another new chemical entity within 30 days or 5 half-lives (whichever is longest) of first administration.
- Previously received AZD1613.
- Involvement in the planning and/or conduct of the study.
- Judgment by the Investigator that the participant should not participate due to minor medical complaints or non-compliance with study procedures.
- Medical dietary restrictions or inability/unwillingness to comply with meals provided during the stay at the Clinical Unit.
- Inability to communicate reliably with the Investigator.
- Vulnerable participants (e.g., kept in detention, protected adults under guardianship).
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States. 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.