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This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4205 | Experimental | Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days |
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| Placebo | Placebo Comparator | placebo single dose in SAD and once daily for 14 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4205 | Drug | SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with adverse events | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs) | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) |
| The number of subjects with abnormal laboratory parameters | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) |
| The number of subjects with abnormal vital signs | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) |
| The number of subjects with abnormal electrocardiogram | To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram | From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory J Tracey | Frontage Clinical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage clinical service | Secaucus | New Jersey | 07094 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37077916 | Derived | Chen K, Guan X, Yang Z, Zhou Y, Liu Z, Deng X, Liu D, Hu P, Chen R. Pharmacokinetic characteristics of golidocitinib, a highly selective JAK1 inhibitor, in healthy adult participants. Front Immunol. 2023 Apr 3;14:1127935. doi: 10.3389/fimmu.2023.1127935. eCollection 2023. |
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| Placebo | Drug | Single dose in SAD and once daily for 14 days |
|