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AZD1163 Safety and Tolerability for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All females must have a negative pregnancy test
BMI between 18 and 32 kg/m^2 and weigh at least 45 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; part 2: days 1-8, 11, 14-16, 22, 29, 57, 113, 225, 281, 365, 450
Awards & highlights

Study Summary

This trial tested a new drug for safety and how well it was tolerated in healthy people.

Who is the study for?
Healthy adults with suitable veins for IV use, a BMI of 18-32 kg/m^2, and weighing at least 45 kg can join. Women must test negative for pregnancy and not be breastfeeding; sexually active women need effective contraception. Exclusions include recent drug trials, cancer history (except certain types), abnormal lab results, infectious diseases like hepatitis or HIV, heart ECG issues, significant health risks as per study criteria, recent serious infections or fever, substance abuse history, severe allergies.Check my eligibility
What is being tested?
The trial is testing the safety and tolerability of AZD1163 given through an IV or as a shot under the skin in healthy people. Participants will either receive AZD1163 or a placebo to compare effects.See study design
What are the potential side effects?
Since this is a study on healthy volunteers to assess safety and tolerability of AZD1163, specific side effects are being investigated but are not yet known. Common side effects may include reactions at the injection site such as pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant.
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My BMI is between 18 and 32, and I weigh at least 45 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; part 2: days 1-8, 11, 14-16, 22, 29, 57, 113, 225, 281, 365, 450
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; part 2: days 1-8, 11, 14-16, 22, 29, 57, 113, 225, 281, 365, 450 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs)
Secondary outcome measures
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
+3 more

Trial Design

17Treatment groups
Active Control
Placebo Group
Group I: Part 1 Cohort 5a SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group II: Part 1 Cohort 7 SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group III: Part 1 Cohort 6 SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group IV: Part 2 Cohort 1 MAD (Japanese participants)Active Control1 Intervention
Participants will receive SC injection of AZD1163 on Days 1 and 15.
Group V: Part 2 Cohort 2 MAD (Japanese participants)Active Control1 Intervention
Participants will receive SC injection of AZD1163 on Days 1 and 15.
Group VI: Part 1 Cohort 1 SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group VII: Part 1 Cohort 4 SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group VIII: Part 2 Cohort 2 MAD (Chinese participants)Active Control1 Intervention
Participants will receive SC injection of AZD1163 on Days 1 and 15.
Group IX: Part 1 Cohort 3 SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group X: Part 1 Cohort 2 SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group XI: Part 2 Cohort 1 MAD (Chinese participants)Active Control1 Intervention
Participants will receive SC injection of AZD1163 on Days 1 and 15.
Group XII: Part 1 Cohort 8 SADActive Control1 Intervention
Participants will receive IV infusion of AZD1163 on Day 1.
Group XIII: Part 1 Cohort 5b SADActive Control1 Intervention
Participants will receive SC injection of AZD1163 on Day 1.
Group XIV: Part 2 Placebo MAD (Chinese participants)Placebo Group1 Intervention
Participants will receive matching SC injection of placebo on Days 1 and 15.
Group XV: Part 2 Placebo MAD (Japanese participants)Placebo Group1 Intervention
Participants will receive matching SC injection of placebo on Days 1 and 15.
Group XVI: Part 1 pooled Placebo SAD IVPlacebo Group1 Intervention
Participants will receive matching IV infusion of placebo on Day 1.
Group XVII: Part 1 pooled Placebo SAD SCPlacebo Group1 Intervention
Participants will receive matching SC injection of placebo on Day 1.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,647 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,124 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility criterion for this clinical trial limited to people under 45 years old?

"Participants willing to take part in this research must be 18 years of age or older, but no more than 55."

Answered by AI

Are there any open opportunities for participation in this clinical trial?

"According to the clinicaltrials.gov database, this particular trial is not taking on patients at present. It was initially published on October 31st 2023 and experienced its last edit 23 days later. Nevertheless, 843 other trials are accepting participants currently."

Answered by AI

Is there a heightened risk associated with Part 1 Cohort 1 SAD?

"Drawing from the limited data available, Power has assigned Part 1 Cohort 1 SAD a safety rating of one on their 3-point scale. This is due to this trial's Phase One status which means that there is little evidence supporting efficacy or safety."

Answered by AI

Is it possible to volunteer for this medical trial?

"To be eligible for the study, potential participants should have no major health issues and must be between 18 to 55 years old. Currently, 64 individuals are in the process of being recruited into this trial."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
2023. "A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06103877.
~18 spots leftby Apr 2025
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