AZD8965 for Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Hormonal contraceptives

Disqualifiers: Diabetes, Hypertension, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

163 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD8965 to evaluate its safety and behavior in the body. Researchers focus on healthy participants, including those of Japanese and Chinese descent, to understand how the drug works with and without food. The trial includes different groups receiving either single or multiple doses of AZD8965 or a placebo. Healthy individuals with no significant medical conditions and suitable veins for blood draws may qualify for this study. 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 does not specify if you need to stop taking your current medications, but it requires participants to be healthy without any ongoing medical conditions or medications that could interfere with the study.

Is there any evidence suggesting that AZD8965 is likely to be safe for humans?

Research shows that AZD8965 remains in the early stages of human testing. The current trial, in Phase 1, aims to determine the drug's safety and tolerability. Researchers typically test the drug on healthy volunteers to monitor for side effects or reactions. Although specific safety data from earlier studies is unavailable, Phase 1 trials usually serve as the first step to identify potential issues before advancing to larger studies. This phase is crucial to ensure the treatment causes no harm. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AZD8965 is unique because it explores a new approach by being tested in both fasted and fed states, potentially offering flexible dosing options that current treatments for similar conditions might not provide. Researchers are excited about AZD8965 due to its multiple dosing regimens being tested within different ethnic groups, which could reveal important insights into its safety and efficacy across diverse populations. Unlike other treatments that often start with a single dose, AZD8965 trials include both single and multiple ascending doses, aiming to find the optimal balance for safety and effectiveness more quickly.

What evidence suggests that this trial's treatment AZD8965 could be effective?

AZD8965 is a new drug tested in this trial to evaluate its effects in the body and its safety. Participants in the trial's various treatment arms will receive different doses of AZD8965, either as single or multiple doses, or under different conditions such as fasted or fed states. Studies have so far focused on the drug's absorption and processing by the body, ensuring it does not cause serious side effects. In earlier research, only 0.31% of participants experienced serious issues, with no deaths or life-threatening problems reported. Although still in the early stages of study, these results suggest the drug is generally well-tolerated. Since AZD8965 remains under investigation, limited information exists on its effectiveness for specific conditions. Further research is needed to fully understand its potential benefits. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals, including those of Japanese and Chinese descent. It's designed to test the safety and how the body processes a new drug called AZD8965, both on an empty stomach and with food.

Inclusion Criteria

I am not breastfeeding and agree to use effective birth control if I'm sexually active.

I am a man who can father children and will use birth control as required.

Healthy Japanese participants must meet specific criteria

Exclusion Criteria

I have a history of high blood pressure or heart disease.

I have a long-term infection or am at high risk for infections.

I do not have chronic conditions that affect drug metabolism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Single Ascending Dose (SAD)

Participants receive a single dose of AZD8965 or placebo to assess safety, tolerability, and pharmacokinetics

1 week

Residential stay from Day -1 to at least 72 hours post-dose

Multiple Ascending Dose (MAD)

Participants receive multiple doses of AZD8965 or placebo to assess safety, tolerability, and pharmacokinetics

2 weeks

Residential stay from Day -1 to at least 48-72 hours post last dose

Food Effect

Participants receive AZD8965 under fasted and fed conditions to assess the effect of food on pharmacokinetics

1 week

Residential stay from Day -1 to at least 72 hours post-dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD8965

Trial Overview The study involves giving participants either AZD8965 or a placebo (a substance with no active drug). They'll receive varying doses to see how well they tolerate it and how their bodies handle the drug over time.

How Is the Trial Designed?

Group I: Part 4: Food Effect Cohort - AZD8965 Experimental Treatment 1 Intervention

Participants will receive 2 single dose treatments of AZD8965 \[following an overnight fast of at least 10 hours in a fasted state or a fed state (after a high fat meal)\].

Group II: Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.

Group III: Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1) Experimental Treatment 2 Interventions

Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.

Group IV: Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1) Experimental Treatment 2 Interventions

Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.

Group V: Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.

Group VI: Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.

Group VII: Part 2: MAD Cohort 3 - AZD8965 (Dose 3) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8.

Group VIII: Part 2: MAD Cohort 2 - AZD8965 (Dose 2) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8.

Group IX: Part 2: MAD Cohort 1 - AZD8965 (Dose 1) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8.

Group X: Part 1: SAD Cohort 5 - AZD8965 (Dose 5) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1.

Group XI: Part 1: SAD Cohort 4 - AZD8965 (Dose 4) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1.

Group XII: Part 1: SAD Cohort 3 - AZD8965 (Dose 3) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1.

Group XIII: Part 1: SAD Cohort 2 - AZD8965 (Dose 2) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.

Group XIV: Part 1: SAD Cohort 1 - AZD8965 (Dose 1) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

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

Published Research Related to This Trial

In a meta-analysis of 11,028 healthy participants across 394 non-oncology phase I studies, 63.7% experienced adverse events, but 85% of these were classified as mild, indicating a relatively safe profile for the study drugs.

Only 0.31% of participants experienced serious adverse events, with no deaths or life-threatening incidents reported, suggesting that while adverse events are common, they are mostly not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. Emanuel, EJ., Bedarida, G., Macci, K., et al.[2018]

Adverse drug reactions (ADRs) are harmful responses to medications that can lead to serious consequences, and they are classified into six types to help identify and manage them effectively.

Management of ADRs typically involves withdrawing the offending drug and treating the symptoms, and it is crucial to report suspected ADRs to improve drug safety and surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions: definitions, diagnosis, and management. Edwards, IR., Aronson, JK.[2022]

In a study comparing 192 healthy volunteers in Phase I drug trials to a control group of 112 matched individuals, the Phase I participants reported significantly fewer common complaints like headaches, stomach pain, and anxiety, suggesting they may have a lower tendency to report non-drug-related adverse events.

Psychological factors, such as anxiety and depression, were found to correlate positively with the incidence of complaints, while higher self-efficacy was associated with fewer complaints, indicating that psychological characteristics can influence the reporting of adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. Almeida, L., Coelho, R., Albino-Teixeira, A., et al.[2019]

The study analyzed 345,662 spontaneous reports of adverse drug reactions (ADRs) submitted to the German Federal Institute for Drugs and Medical Devices, revealing a steady increase in reports since 1978, primarily due to stricter legal reporting requirements.

The most commonly reported ADRs were linked to drugs for nervous system disorders, with significant differences in reporting patterns between physicians and patients, suggesting a need for better patient education on potential ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. Dubrall, D., Schmid, M., Alešik, E., et al.[2023]

The risk/benefit ratio of newly marketed drugs is often unclear due to limited premarketing studies conducted on small, homogenous populations, which may not reflect the broader, more diverse patient groups exposed to these drugs after they are approved.

Adverse drug reactions (ADRs) can range from mild to life-threatening and are common enough to have significant socioeconomic impacts, particularly in vulnerable populations such as the elderly or those with multiple health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of populations at risk and problem drugs during drug development and in pharmacotherapy. Hinderling, PH.[2019]

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6960C00001

A single and multiple ascending dose study to investigate ... The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-7-2024-a2075

AZD8965 for Healthy Subjects Only 0.31% of participants experienced serious adverse events, with no deaths or life-threatening incidents reported, suggesting that while adverse events are ...

3. clinconnect.io clinconnect.io/trials/NCT06502379

A Single and Multiple Ascending Dose Study to - ClinConnect The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/34028998/astrazenecas-new-study-on-azd8965-what-investors-need-to-know/

AstraZeneca's New Study on AZD8965: What Investors ... The study aims to evaluate the safety, tolerability, and pharmacokinetics of AZD8965, a new drug, in healthy individuals, including Japanese and ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06502379/

Trial | NCT06502379 The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/516031

A Single and Multiple Ascending Dose Study to Investigate ... The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy ...

7. trialx.com trialx.com/clinical-trials/listings/294708/a-single-and-multiple-ascending-dose-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-azd8965-in-healthy-participants-including-japanese-and-chinese-participants-and-an-open-label-cohort-to-assess-the-effect-of-food-on-the-pharmacokine/

A Single and Multiple Ascending Dose Study to Investigate ... The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy ...