Safety Study of AZD6912 in Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the safety and tolerability of a new drug, AZD6912, when administered in different doses, and to understand how the body processes it. The trial examines the drug's effects in healthy individuals, with a specific focus on Japanese participants. Individuals who are generally healthy, without a history of significant diseases or infections, and who meet certain weight and lifestyle criteria may be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AZD6912, the treatment being tested in this trial, is in the early stages of human testing, so limited information exists about its safety. The study aims to determine how well people can tolerate the drug and identify any side effects.
As AZD6912 remains in early trials, researchers continue to collect safety information. In such studies, the primary goal is to assess the drug's safety for humans and identify any side effects. Researchers closely monitor participants for any harmful effects.
Prospective participants should understand that early trials are crucial for assessing the basic safety of a new treatment, but they may also involve unknown risks.12345Why are researchers excited about this trial's treatment?
AZD6912 is unique because it offers a new approach to treatment by possibly targeting specific biological pathways that current therapies don't address. Unlike existing medications, which often involve standard approaches like inhibiting certain enzymes or receptors, AZD6912 may work by influencing novel molecular targets, potentially leading to improved outcomes. Researchers are excited about this treatment because its innovative mechanism of action could provide better efficacy and safety profiles compared to the current standard of care, opening up new possibilities for patient care.
What evidence suggests that this trial's treatments could be effective?
AZD6912 is a new treatment tested in this trial to ensure its safety and understand its mechanism in the body. Currently, limited information exists on its effectiveness for specific health conditions. The primary focus has been on confirming its safety and observing its behavior in the body. Researchers are studying it in healthy volunteers to monitor its effects and how the body processes it. Although detailed results are not yet available, the trial examines how different doses of AZD6912 impact the body. This research lays the groundwork for future studies to test its effectiveness for specific health issues.12346
Are You a Good Fit for This Trial?
This trial is for healthy individuals of Japanese descent, with a BMI between 18 and 30 kg/m2 and weighing at least 50 kg. Participants must be born to two Japanese parents and four Japanese grandparents, have lived in Japan, not abroad for over five years, maintain a consistent lifestyle since leaving Japan, and use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single ascending dose of AZD6912 or placebo and are monitored in the Clinical Unit
Follow-up
Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD6912
- Placebo
Trial Overview
The study tests AZD6912 given under the skin against a placebo in healthy people to check its safety, how well it's tolerated, how the body processes it (PK), and how it affects the body (PD).
How Is the Trial Designed?
9
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive AZD6912.
Participants will receive AZD6912.
Participants will receive AZD6912 Dose 6.
Participants will receive AZD6912 Dose 5.
Participants will receive AZD6912 Dose 4.
Participants will receive AZD6912 Dose 3.
Participants will receive AZD6912 Dose 2.
Participants will receive AZD6912 Dose 1.
Participants will receive Placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
NCT06115967 | A Study to Assess the Safety, Tolerability ...
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered ...
A Study to Assess the Safety, Tolerability ...
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered ...
A Phase 1 double-blind, SAD study to assess safety ...
The trial is a single centre, double-blind trial in up to approximately 72 healthy males and females between the ages of 18 and 50 years.
Safety Study of AZD6912 in Healthy Volunteers
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered ...
AZD6912 / AstraZeneca
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants (clinicaltrials.gov) - P1 ...
6.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/33650193/astrazenecas-phase-i-study-of-azd6912-a-potential-game-changer/AstraZeneca's Phase I Study of AZD6912: A Potential ...
The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD6912, a new drug administered subcutaneously ...
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