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AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels
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L'essai clinique NCT06980428 est conçu pour étudier le treatment de Participants en bonne santé. Il s'agit d'un essai interventionnel en Phase I. Son statut actuel est : en recrutement. L'essai a débuté le 27 mai 2025 et vise à recruter 120 participants. Dirigé par AstraZeneca, l'essai devrait être terminé d'ici le 4 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 1 décembre 2025.
Résumé succinct
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp[a]) levels.
Description détaillée
This is a first time in human, placebo-controlled, single and multiple ascending dose (SAD and MAD) study in healthy male and female (of non-childbearing potential) participants (Part A) or healthy participants (of non-childbearing potential) with elevated Lp(a) levels (≥ 30 mg/dL; Part B).
The study consists of 2 parts: Part A (SAD) and Part B (MAD).
Part A of the study will consist of Part A1 and Part A2, comprising:
- A Screening Period of maximum 28 days.
- Admission to study site (Day -1).
- A Treatment Period (Day 1 to Day 15 at the study site) with a single dose of AZD4954 or placebo on Day 1.
- A Follow-up Visit within 26 to 30 days after the investigational medicinal product (IMP) dose for all cohorts (Day 29 ±2 days).
Part B of the study will comprise:
- A Screening Period of maximum 28 days.
- Admission to study site (Day -1).
- A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21) in the global MAD cohorts and for 14 days (Day 1 to 14) in Japanese MAD cohorts.
- A Follow-up Visit within 26 to 30 days after the last IMP dose (Day 49 ±2 days for the global MAD cohorts and Day 42 ±2 days for the Japanese MAD cohorts).
Titre officiel
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4954 Following Single and Multiple Ascending Dose Administration to Healthy Participants With or Without Elevated Lp(a) Levels
Conditions
Participants en bonne santéAutres identifiants de l'essai
- D7300C00001
Numéro NCT
Date de début (réel)
2025-05-27
Dernière mise à jour publiée
2025-12-01
Date de fin (estimée)
2026-12-04
Inscription (estimée)
120
Type d'essai
Interventionnel
PHASE
Phase I
Statut
En recrutement
Mots clés
Dyslipidemia
Lipoprotein(a)
Lipoprotein(a)
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Séquentiel
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPart A1: SAD Cohort 1 - AZD4954 (Dose 1) Participants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Cohort 2 - AZD4954 (Dose 2) Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Cohort 3 - AZD4954 (Dose 3) Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Cohort 4 - AZD4954 (Dose 4) Participants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Cohort 5 - AZD4954 (Dose 5) Participants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Optional Cohort 6 - AZD4954 (Dose 6) Participants will receive a single dose of AZD4954 (Dose 6) or matching placebo on Day 1. This additional cohort may be added depending on the findings. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2) Japanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3) Japanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Optional Cohort 3 (Japanese) - AZD4954 This additional cohort may be added depending on the findings. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5) Chinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart A2: SAD Food Effect Cohort - AZD4954 (Dose 2) Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart B: Global MAD Cohort 1 - AZD4954 (Dose 1) Participants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart B: Global MAD Cohort 2 - AZD4954 (Dose 2) Participants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart B: Global MAD Cohort 3 - AZD4954 (Dose 3) Participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart B: Optional Global MAD Cohort 4 - AZD4954 Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
ExpérimentalPart B: MAD Cohort (Japanese) - AZD4954 (Dose 3) Japanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 14 days. | AZD4954 AZD4954 will be administered orally. PLACEBO Placebo will be administered orally. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | To assess the safety and tolerability of AZD4954 following oral administration of SAD (Part A). | From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days) |
Part B: Number of participants with AEs and SAEs | To assess the safety and tolerability of AZD4954 following oral administration of MAD (Part B). | From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 49±2 days) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Up to Day 29±2 days |
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Part B: Area under concentration-time curve in the dosing interval (AUCtau) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Up to Day 49±2 days |
Dose normalized AUClast (AUClast/D) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Dose normalized AUCinf (AUCinf/D) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Part B: Dose normalized AUCtau (AUCtau/D) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Up to Day 49±2 days |
Apparent total body clearance (CL/F) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Maximum observed drug concentration (Cmax) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Dose normalized Cmax (Cmax/D) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Terminal elimination half-life (t1/2λz) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Time of last quantifiable concentration (tlast) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Time to reach maximum observed concentration (tmax) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Apparent volume of distribution based on the terminal phase (Vz/F) | To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days |
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2]) | To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 15; Part B: Up to Day 22 |
Cumulative amount of unchanged drug excreted into urine (Aeinf) | To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 15; Part B: Up to Day 22 |
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2]) | To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 15; Part B: Up to Day 22 |
Renal clearance (CLR) | To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954. | Part A: Up to Day 15; Part B: Up to Day 22 |
Part B: Absolute change from baseline in serum Lp(a) | To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing. | Up to Day 49±2 days |
Part B: Relative change from baseline in serum Lp(a) | To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing. | Up to Day 49±2 days |
Part B: Absolute change from baseline in Lp(a) intact assay | To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing. | Up to Day 49±2 days |
Part B: Relative change from baseline in Lp(a) intact assay | To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing. | Up to Day 49±2 days |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
Parts A and B:
Participants with plasminogen level (concentration) within normal range at the Screening Visit.
All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
Females of non-childbearing potential must be confirmed at the Screening Visit.
Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.
Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive.
For Japanese and Chinese participants (Parts A and B):
A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.
A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
Only Part B:
For Part B (Global MAD Cohorts), at the Screening Visit participants must have elevated Lp(a) ≥ 30 mg/dL.
Parts A and B:
- History of any clinically important disease or disorder.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Participants with known bleeding or coagulation disorders.
- Participants who have an elevated high-sensitivity C-reactive protein (> 3 mg/L) or have a prothrombin time/international normalized ratio (PT/INR) or activated partial thromboplastin time (aPTT) > 1.25 times × upper limit normal (ULN).
- Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values.
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
AstraZeneca778 essais cliniques actifs à explorerContact central de l'essai
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
5 Centres de l'essai dans 1 pays
California
Research Site, Glendale, California, 91206, United States
En recrutement
Florida
Research Site, Inverness, Florida, 34452, United States
Pas encore en recrutement
Research Site, Jacksonville, Florida, 32216, United States
Pas encore en recrutement
Maryland
Research Site, Brooklyn, Maryland, 21225, United States
En recrutement
Texas
Research Site, San Antonio, Texas, 78229, United States
Pas encore en recrutement