AsthmaPhase 1NCT05110976
A Study to Investigate the Safety, Tolerability and Effects of AZD8630 in Healthy Subjects and Subjects With Asthma on Inhaled Corticosteroids and Long-acting Beta-agonists
A Phase 1 study testing AZD8630 in people with Asthma, run by AstraZeneca at 29 sites in 3 countries.
Trial summary
This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part A) and adult asthma patients on medium to high dose inhaled corticosteroids / Long-acting beta-agonists (Part B) Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- AZD8630
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 16 Dec 2021to 2 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A (Healthy participants):
- Healthy participants aged 18 to 55 years, inclusive:
- Japanese participants must be aged 20 to 55 years, inclusive
- Chinese participants must be aged 18 to 45 years, inclusive
- Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test on admission to the Clinical Unit, must not be lactating, and must be of non childbearing potential, confirmed at the Screening Visit
- Have a body mass index (BMI) between 18 and 30 kg/m^2 inclusive and weigh at least 45 kg.
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- Healthy participant must have a forced expiratory volume in 1 second (FEV1) ≥ 80% of the predicted value regarding age, height, gender, and ethnicity at the Screening Visit.
- Male participants and their women of childbearing potential partners (WOCPB) should be willing to use highly effective contraception measures and male participants should refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the study Follow up Visit.
- Part A2 and Part A4 (Chinese population only): Chinese participants must have been born in China, have all parents and grandparents of Chinese origin, and not have lived outside of China for more than 10 years.
- Part A2 and Part A4 (Japanese population only): Japanese participants must have been born in Japan, have all parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 10 years.
- Part B (Participants with Asthma):
- Male and female including WOCBP participants with asthma aged 18 to 75 years inclusive, with suitable veins for cannulation or repeated venipuncture.
- Have a BMI between 18 and 35 kg/m^2 inclusive and weigh at least 45 kg.
- Confirmed physician-led diagnosis of asthma for > 6 months before the Screening Visit.
- Any of the following assessments within the last 10 years to confirm variable airflow obstruction: Variability between clinic visits: FEV1 > 12% and 200 mL; Response to 4 weeks' anti-inflammatory therapy: FEV1 > 12% and 200 mL; Exercise challenge test: FEV1 fall > 10% and 200mL; Methacholine challenge test: FEV1 ≥ 20% fall at < 8 mg/mL; Indirect challenge test: FEV1 ≥ 15% fall; Or in the screening period: Variability between clinic visits: FEV1 > 12% and 200 mL; Peak expiratory flow rate (PEFR) for 2 weeks during run-in: PEFR average daily variability > 10%.
- Pre-bronchodilator FEV1 ≥ 40% and < 85% predicted at the Screening Visit.
- Have a fractional exhaled nitric oxide (FeNO) of ≥ 35 ppb at the Screening Visit and ≥ 30 ppb at randomisation.
- Asthma Control Questionnaire -5 score of ≥ 0.75 and ≤ 3.0 at screening.
- During 7 consecutive days within screening, immediately prior to randomisation demonstrates ≥ 65% adherence to each of the following:
- Once daily home FeNO
- Twice daily home spirometry measurements
- Twice daily entries in the eDiary
- Females must have a negative serum pregnancy test at the Screening Visit. Additionally, WOCBP must have a negative urine pregnancy test at Visit 2 (prior to randomisation) and must not be lactating.
- Male participants and their WOCBP partners should be willing to use highly effective contraception measures and male participants should refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the study Follow-up Visit.
- WOCBP must be willing to use highly effective contraception measures from the first day of dosing until 3 months after the study Follow up Visit.
Who cannot join
- Part A (Healthy participants)
- History of following: any clinically important disease or disorder; any upper or lower respiratory tract infection during screening period; active tuberculosis or current positive result for Interferon gamma release assay at screening; clinically significant history of atopy or allergy to common allergens including house dust mite and pollens, or a history of childhood asthma.
- Active or previous hepatitis B, hepatitis C, or Human immunodeficiency virus at the Screening Visit, and other latent or chronic infections.
- History of severe COVID-19 (Coronavirus disease 2019) infection requiring hospitalization
- SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) first vaccination within 30 days prior to screening.
- SARS-CoV-2 second or booster vaccination within 10 days of screening.
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- Unwilling to defer SARS-CoV-2 vaccination during the study period.
- History of cancer within last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of skin or in situ carcinoma of cervix treated and considered cured. Any history of lymphoma is not allowed.
- Have received live or live attenuated vaccine in 4 weeks prior to randomisation.
- History of acquired or inherited immunodeficiency disorders including but not limited to HIV, COVID-19, or taking immune replacement therapy.
- C-reactive protein above upper limit of laboratory reference range
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results and abnormal vital signs at the Screening Visit.
- Current smokers or those who have smoked or used nicotine or inhalational cannabis/marijuana products. History of alcohol abuse or drug abuse.
- Use of any prescribed or nonprescribed medication during the 2 weeks prior to the first administration of investigational medicinal product.
- Has received another new chemical entity.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8630.
- History of anaphylaxis to any previous biological therapy.
- Participants who have previously received AZD8630.
- Part B (Participants with Asthma):
- History of following: any clinically important disease or disorder; any chronic respiratory disorders (except asthma) such as Chronic obstructive pulmonary disease, bronchiectasis, or IPF; clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening.
- Acute exacerbation of asthma requiring hospitalisation and/or attendance at an emergency department and/or systemic corticosteroids within 6 weeks of randomisation.
- History of active TB or a current positive result for IGRA at screening.
- History of severe COVID-19 infection requiring hospitalisation.
- SARS-CoV-2 first vaccination within 30 days prior to screening.
- SARS-CoV-2 second or booster vaccination within 10 days of screening.
- Confirmed COVID-19 infection during screening, prior to randomisation.
- History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed.
- Have received live or live attenuated vaccine in the 4 weeks prior to randomisation.
- C-reactive protein above the upper limit of laboratory reference range at screening.
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results, and abnormal vital signs at the Screening Visit.
- Current smokers or those who have smoked or used nicotine or inhalational cannabis/marijuana products. History of alcohol or drug abuse.
- Positive screen for drugs of abuse or cotinine (nicotine) prior to randomisation.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks before first administration of study drug.
- Use of any prescribed or nonprescribed medication during the 2 weeks prior to the first administration of study drug.
- Use of following medicines within specified time before Screening: (a) Any biologics for asthma within 6 months prior to Screening; (b) Systemic or intranasal steroids within 4 weeks prior to Screening; (c) Xanthines, anticholinergics, or cromoglycate within 1 week prior to Screening; (d) Short acting bronchodilator other than for rescue and within 12 hours prior to Screening and Day -1 assessments.
- History of anaphylaxis or ongoing clinically important serious allergy, or history of hypersensitivity or anaphylaxis to drugs with a similar chemical structure or class to AZD8630.
- History of anaphylaxis to any previous biological therapy.
- Pregnancy or intention to become pregnant during course of study, breastfeeding, or unwillingness to use a highly effective method of contraception throughout study in female participants of childbearing potential or lactating woman.
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
United States18 sites
Research Site
Ann Arbor, Michigan, 48105
Research Site
Bakersfield, California, 93301
Research Site
Boise, Idaho, 83706
Research Site
El Paso, Texas, 79903
Research Site
Glendale, California, 91206
Research Site
Homestead, Florida, 33030
Research Site
Miami, Florida, 33122
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33155
Research Site
Miami, Florida, 33173
Research Site
Miami, Florida, 33175
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Portland, Oregon, 97202
Research Site
Raleigh, North Carolina, 27607
Research Site
San Jose, California, 95117
Research Site
Tempe, Arizona, 85283
Research Site
Toledo, Ohio, 43617
Research Site
White Marsh, Maryland, 21162
Germany6 sites
Research Site
Berlin, 10119
Research Site
Frankfurt, 60596
Research Site
Großhansdorf, 22927
Research Site
Lübeck, 23552
Research Site
Magdeburg, 39120
Research Site
Wiesbaden, 65187
United Kingdom5 sites
Research Site
Bradford, BD9 6RJ
Research Site
London, HA1 3UJ
Research Site
London, W12 0HS
Research Site
Manchester, M23 9QZ
Research Site
Portsmouth, PO6 3LY
About this study
Official title: Phase I, Randomised, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8630 in Healthy Adult Subjects (Part A) and Adults With Asthma on Medium to High Dose Inhaled Corticosteroids and Long-acting Beta-agonists (Part B)
This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part A) and adult asthma patients on medium to high dose inhaled corticosteroids / Long-acting beta-agonists (Part B)
Read the detailed description
The study is divided in 2 parts, A and B.
Part A will be conducted in healthy adults, whereas Part B will be conducted in adult asthma patients on medium/high dose inhaled corticosteroids (ICS)/long-acting beta-agonists (LABA) to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of AZD8630 by dry powder inhaler (DPI) administration. Part A includes the assessment of the PK and safety of intravenous (IV) AZD8630. Part A consists of single ascending dose (SAD) and multiple ascending dose (MAD) cohorts in sequential order and Part B will be evaluating multiple dose levels.
Part A: This part will consist 4 sub-parts and will include healthy participants and healthy participants of Chinese and Japanese ethnicity. These participants will randomized to receive AZD8630 and to receive placebo.
- Sub-Part A1, SAD in healthy participants (one cohort in Sub-Part A1 will receive IV AZD8630 [IV formulation])
- Sub-Part A2, SAD in healthy participants of Chinese and Japanese ethnicity
- Sub-Part A3, MAD in healthy participants
- Sub-Part A4, MAD in healthy participants of Chinese and Japanese ethnicity
Part B: Adult asthma patients will be randomized to one of 3 inhaled dose levels of AZD8630 or placebo.
The expected duration of study participation for each participants in the part A is up to 87 days, and each patients in the Part B is up to 70 days.
- Conditions
- Asthma
- Being tested
- AZD8630, Placebo
- Keywords
- Healthy adult participants, Healthy participants of Chinese and Japanese ethnicity, Corticosteroids Beta-agonists, Multiple ascending dose, Single ascending dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8630Drug
Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned.
PlaceboDrug
Participants will receive Inhaled or IV doses of placebo as per the arm they are assigned.
| Study group | Role | What they receive |
|---|---|---|
| Part A1: SAD (AZD8630) | Experimental | Healthy participants will receive single inhaled doses 1 to 5 of AZD8630. Receives: Drug: AZD8630 |
| Part A1: IV (AZD8630) | Experimental | Healthy participants will receive a single IV dose of AZD8630. Receives: Drug: AZD8630 |
| Part A1: IV (Placebo) | Placebo comparator | Healthy participants will receive single IV dose of Placebo. Receives: Drug: Placebo |
| Part A2: SAD (AZD8630) | Experimental | Healthy participants of Chinese and Japanese ethnicity will receive single inhaled dose 5 of AZD8630. Receives: Drug: AZD8630 |
| Part A3: MAD (AZD8630) | Experimental | Healthy participants will receive once daily inhaled doses 3, 4, and 5 of AZD8630. Receives: Drug: AZD8630 |
| Part A4: MAD (AZD8630) | Experimental | Healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose 5 of AZD8630. Receives: Drug: AZD8630 |
| Part A: SAD (Placebo) | Placebo comparator | Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive single inhaled doses of placebo. Receives: Drug: Placebo |
| Part A: MAD (Placebo) | Placebo comparator | Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose of placebo. Receives: Drug: Placebo |
| Part B (AZD8630) | Experimental | Participants with asthma will be randomized to one of 3 inhaled dose levels 3, 6, and 7 of AZD8630 once daily. Receives: Drug: AZD8630 |
| Part B (Placebo) | Placebo comparator | Participants with asthma will receive once daily inhaled dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and Part B: Number of participants with adverse events
Safety and tolerability of inhaled AZD8630 in healthy participants and participants with asthma will be assessed.
Measured: Until Follow-up (FU) Visit/Early Termination (ET) Visit (Part A: 7-day post-dose for SAD; 10-day post-last dose for MAD) and Part B: Until FU Visit/ET Visit (10-day post-last dose)
Part A (IV cohort): Time to reach maximum observed concentration (tmax) of AZD8630
tmax of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Time of last observed quantifiable concentration (tlast) of AZD8630
tlast of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Maximum observed serum (peak) drug concentration (Cmax) of AZD8630
Cmax of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Partial area under the serum concentration-time curve from 0 to time 24 hours post-dose [AUC(0-24)] of AZD8630
AUC(0-24) of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast) of AZD8630
AUClast of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Area under serum concentration-time curve from zero to infinity (AUCinf) of AZD8630
AUCinf of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Terminal rate constant (λz) of AZD8630
λz of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) of AZD8630
t1/2λz) of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Mean residence time of the unchanged drug in the systemic circulation (MRTinf) of AZD8630
MRTinf of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Total body clearance of drug from serum after IV administration (CL) of AZD8630
CL of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV cohort): Volume of distribution at steady state (Vss) of AZD8630
Vss of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV Cohort): Volume of distribution of drug from serum after IV administration (Vz) of AZD8630
Vz of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Measured: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Part A (IV Cohort): Number of participants with adverse events
Safety and tolerability of IV AZD8630 in healthy participants will be assessed.
Measured: Until Follow-up (FU) Visit/Early Termination (ET) Visit (7-day post-dose)
Secondary outcomes (22)
Part A and Part B: Time to reach maximum observed concentration (tmax) of AZD8630
tmax of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A (A1 and A2 only): Time of last observed quantifiable concentration (tlast) of AZD8630
tlast of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose)
Part A and Part B: Maximum observed serum (peak) drug concentration (Cmax) of AZD8630
Cmax of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Maximum observed serum (peak) drug concentration divided by the lung-delivered dose (LDD) [Cmax/D] of AZD8630
Cmax/D of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Concentration at the end of the dosing interval (Ctrough) [repeat dose only] of AZD8630
Ctrough of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Partial area under the serum concentration-time curve from 0 to time 24 hours post-dose [AUC(0-24)] of AZD8630
AUC(0-24) of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A and Part B: Partial area under the serum concentration-time curve from 0 to time 24 hours post-dose divided by the LDD [AUC(0-24)/D] of AZD8630
AUC(0-24)/D of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A: Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast) of AZD8630
AUClast of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose)
Part A: Area under the serum concentration-time curve from time zero to time of last quantifiable drug concentration divided by the LDD (AUClast/D) of AZD8630
AUClast/D of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose)
Part A and Part B: Area under serum concentration-time curve from zero to infinity (AUCinf) of AZD8630
AUCinf of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A and Part B: Area under the serum concentration-time curve from time zero extrapolated to infinity divided by the LDD (AUCinf /D) of AZD8630
AUCinf /D of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A and Part B: Area under serum concentration-time curve in the dosing interval t (AUCt) of AZD8630
AUCt of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Area under serum concentration-time curve in the dosing interval t divided by the LDD (AUCt/D) of AZD8630
AUCt/D of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Terminal rate constant (λz) of AZD8630
λz of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) of AZD8630
t1/2λz of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Mean residence time of the unchanged drug in the systemic circulation (MRTinf) of AZD8630
MRTinf of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Apparent total body clearance of drug from serum after extravascular administration (inhalation administration only) [CL/F] of AZD8630
CL/F of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Apparent volume of distribution following extravascular administration based on terminal phase (inhalation administration only) [Vz/F] of AZD8630
Vz/F of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Accumulation ratio based upon AUCt [Rac(AUC)] of AZD8630
Rac(AUC) of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (MAD) Day 14; Part B- Day 28
Part A and Part B: Accumulation ratio based upon Cmax [Rac(Cmax)] of AZD8630
Rac(Cmax) of AZD8630 in healthy participants, including participants of Japanese and Chinese ethnicity will assessed.
Measured: Pre-dose and Post-dose: Part A- (MAD) Day 14; Part B- Day 28
Part A and Part B: Number of participants with presence of anti-drug antibodies (ADAs)
Immunogenicity of AZD8630 following single and multiple dose administration will be characterized.
Measured: Pre-dose: Part A- (SAD) Days 1 to 3 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1, 7, 14, and 28, and FU Visit/ ET Visit (10-day post-last dose)
Part B: Change from baseline in fractional exhaled nitric oxide (FeNO) levels
The PD effect of AZD8630 on FeNO versus placebo following daily inhaled AZD8630 will be assessed.
Measured: From Screening (Up to days 28 before Day 1) until Day 29 (end of the treatment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start16 Dec 2021
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110976
- Sponsor's protocol ID
- D6830C00001
- Other IDs
- 2021-004000-18
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomised, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8630 in Healthy Adult Subjects (Part A) and Adults With Asthma on Medium to High Dose Inhaled Corticosteroids and Long-acting Beta-agonists (Part B)
- ClinicalTrials.gov ID
- NCT05110976
- Acronym / sponsor ID
- D6830C00001
- Conditions
- Asthma
- Keywords
- Healthy adult participants, Healthy participants of Chinese and Japanese ethnicity, Corticosteroids Beta-agonists, Multiple ascending dose, Single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part A) and adult asthma patients on medium to high dose inhaled corticosteroids / Long-acting beta-agonists (Part B)
Detailed description
The study is divided in 2 parts, A and B.
Part A will be conducted in healthy adults, whereas Part B will be conducted in adult asthma patients on medium/high dose inhaled corticosteroids (ICS)/long-acting beta-agonists (LABA) to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of AZD8630 by dry powder inhaler (DPI) administration. Part A includes the assessment of the PK and safety of intravenous (IV) AZD8630. Part A consists of single ascending dose (SAD) and multiple ascending dose (MAD) cohorts in sequential order and Part B will be evaluating multiple dose levels.
Part A: This part will consist 4 sub-parts and will include healthy participants and healthy participants of Chinese and Japanese ethnicity. These participants will randomized to receive AZD8630 and to receive placebo.
- Sub-Part A1, SAD in healthy participants (one cohort in Sub-Part A1 will receive IV AZD8630 [IV formulation])
- Sub-Part A2, SAD in healthy participants of Chinese and Japanese ethnicity
- Sub-Part A3, MAD in healthy participants
- Sub-Part A4, MAD in healthy participants of Chinese and Japanese ethnicity
Part B: Adult asthma patients will be randomized to one of 3 inhaled dose levels of AZD8630 or placebo.
The expected duration of study participation for each participants in the part A is up to 87 days, and each patients in the Part B is up to 70 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A1: SAD (AZD8630) | Experimental | Drug: AZD8630Healthy participants will receive single inhaled doses 1 to 5 of AZD8630. |
| Part A1: IV (AZD8630) | Experimental | Drug: AZD8630Healthy participants will receive a single IV dose of AZD8630. |
| Part A1: IV (Placebo) | Placebo comparator | Drug: PlaceboHealthy participants will receive single IV dose of Placebo. |
| Part A2: SAD (AZD8630) | Experimental | Drug: AZD8630Healthy participants of Chinese and Japanese ethnicity will receive single inhaled dose 5 of AZD8630. |
| Part A3: MAD (AZD8630) | Experimental | Drug: AZD8630Healthy participants will receive once daily inhaled doses 3, 4, and 5 of AZD8630. |
| Part A4: MAD (AZD8630) | Experimental | Drug: AZD8630Healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose 5 of AZD8630. |
| Part A: SAD (Placebo) | Placebo comparator | Drug: PlaceboHealthy participants and healthy participants of Chinese and Japanese ethnicity will receive single inhaled doses of placebo. |
| Part A: MAD (Placebo) | Placebo comparator | Drug: PlaceboHealthy participants and healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose of placebo. |
| Part B (AZD8630) | Experimental | Drug: AZD8630Participants with asthma will be randomized to one of 3 inhaled dose levels 3, 6, and 7 of AZD8630 once daily. |
| Part B (Placebo) | Placebo comparator | Drug: PlaceboParticipants with asthma will receive once daily inhaled dose of placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Healthy participants aged 18 to 55 years, inclusive:
- Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test on admission to the Clinical Unit, must not be lactating, and must be of non childbearing potential, confirmed at the Screening Visit
- Have a body mass index (BMI) between 18 and 30 kg/m^2 inclusive and weigh at least 45 kg.
- Healthy participant must have a forced expiratory volume in 1 second (FEV1) ≥ 80% of the predicted value regarding age, height, gender, and ethnicity at the Screening Visit.
- Male participants and their women of childbearing potential partners (WOCPB) should be willing to use highly effective contraception measures and male participants should refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the study Follow up Visit.
Key exclusion criteria (38 listed)
- Part A (Healthy participants)
- History of following: any clinically important disease or disorder; any upper or lower respiratory tract infection during screening period; active tuberculosis or current positive result for Interferon gamma release assay at screening; clinically significant history of atopy or allergy to common allergens including house dust mite and pollens, or a history of childhood asthma.
- Active or previous hepatitis B, hepatitis C, or Human immunodeficiency virus at the Screening Visit, and other latent or chronic infections.
- History of severe COVID-19 (Coronavirus disease 2019) infection requiring hospitalization
- SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) first vaccination within 30 days prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD8630Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned. | Drug | Part A1: IV (AZD8630), Part A1: SAD (AZD8630), Part A2: SAD (AZD8630), Part A3: MAD (AZD8630), Part A4: MAD (AZD8630), Part B (AZD8630) |
| PlaceboParticipants will receive Inhaled or IV doses of placebo as per the arm they are assigned. | Drug | Part A1: IV (Placebo), Part A: MAD (Placebo), Part A: SAD (Placebo), Part B (Placebo) |
Primary outcome
Part A and Part B: Number of participants with adverse events
Time frame: Until Follow-up (FU) Visit/Early Termination (ET) Visit (Part A: 7-day post-dose for SAD; 10-day post-last dose for MAD) and Part B: Until FU Visit/ET Visit (10-day post-last dose)
Safety and tolerability of inhaled AZD8630 in healthy participants and participants with asthma will be assessed.
Part A (IV cohort): Time to reach maximum observed concentration (tmax) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
tmax of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed
Part A (IV cohort): Time of last observed quantifiable concentration (tlast) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
tlast of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed
Part A (IV cohort): Maximum observed serum (peak) drug concentration (Cmax) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Cmax of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Partial area under the serum concentration-time curve from 0 to time 24 hours post-dose [AUC(0-24)] of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
AUC(0-24) of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
AUClast of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Area under serum concentration-time curve from zero to infinity (AUCinf) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
AUCinf of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Terminal rate constant (λz) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
λz of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
t1/2λz) of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Mean residence time of the unchanged drug in the systemic circulation (MRTinf) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
MRTinf of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Total body clearance of drug from serum after IV administration (CL) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
CL of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV cohort): Volume of distribution at steady state (Vss) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Vss of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV Cohort): Volume of distribution of drug from serum after IV administration (Vz) of AZD8630
Time frame: Pre-dose and Post-dose on Days 1 to 4 and Follow-up Visit/ET Visit (7-day post-dose)
Vz of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Part A (IV Cohort): Number of participants with adverse events
Time frame: Until Follow-up (FU) Visit/Early Termination (ET) Visit (7-day post-dose)
Safety and tolerability of IV AZD8630 in healthy participants will be assessed.
22 secondary outcomes
Part A and Part B: Time to reach maximum observed concentration (tmax) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A (A1 and A2 only): Time of last observed quantifiable concentration (tlast) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose)
Part A and Part B: Maximum observed serum (peak) drug concentration (Cmax) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Maximum observed serum (peak) drug concentration divided by the lung-delivered dose (LDD) [Cmax/D] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Concentration at the end of the dosing interval (Ctrough) [repeat dose only] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Partial area under the serum concentration-time curve from 0 to time 24 hours post-dose [AUC(0-24)] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A and Part B: Partial area under the serum concentration-time curve from 0 to time 24 hours post-dose divided by the LDD [AUC(0-24)/D] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A: Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose)
Part A: Area under the serum concentration-time curve from time zero to time of last quantifiable drug concentration divided by the LDD (AUClast/D) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose)
Part A and Part B: Area under serum concentration-time curve from zero to infinity (AUCinf) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A and Part B: Area under the serum concentration-time curve from time zero extrapolated to infinity divided by the LDD (AUCinf /D) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), and Day 1 for MAD and Part B
Part A and Part B: Area under serum concentration-time curve in the dosing interval t (AUCt) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Area under serum concentration-time curve in the dosing interval t divided by the LDD (AUCt/D) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Terminal rate constant (λz) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Mean residence time of the unchanged drug in the systemic circulation (MRTinf) of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Apparent total body clearance of drug from serum after extravascular administration (inhalation administration only) [CL/F] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Apparent volume of distribution following extravascular administration based on terminal phase (inhalation administration only) [Vz/F] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (SAD) Days 1 to 4 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1 to 14, Day 28, Day 29, and FU Visit/ ET Visit (10-day post-last dose)
Part A and Part B: Accumulation ratio based upon AUCt [Rac(AUC)] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (MAD) Day 14; Part B- Day 28
Part A and Part B: Accumulation ratio based upon Cmax [Rac(Cmax)] of AZD8630
Time frame: Pre-dose and Post-dose: Part A- (MAD) Day 14; Part B- Day 28
Part A and Part B: Number of participants with presence of anti-drug antibodies (ADAs)
Time frame: Pre-dose: Part A- (SAD) Days 1 to 3 and FU Visit/ET Visit (7-day post-dose), (MAD) Days 1 to 17 and FU Visit/ET Visit (10-day post-last dose); Part B- Days 1, 7, 14, and 28, and FU Visit/ ET Visit (10-day post-last dose)
Part B: Change from baseline in fractional exhaled nitric oxide (FeNO) levels
Time frame: From Screening (Up to days 28 before Day 1) until Day 29 (end of the treatment visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8630 in people with Asthma, run by AstraZeneca at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A and Part B: Number of participants with adverse events (time frame: Until Follow-up (FU) Visit/Early Termination (ET) Visit (Part A: 7-day post-dose for SAD; 10-day post-last dose for MAD) and Part B: Until FU Visit/ET Visit (10-day post-last dose)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.