Oct. 17, 2023 |
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Dec. 09, 2023 |
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jRCT2071230075 |
A Randomised, Single-blind, Single-centre, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants |
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A study to investigate safety, tolerability, and pharmacokinetics of AZD7503 in healthy Japanese participants. |
Ageishi Yuji |
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Astrazeneka K.K |
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3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka |
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+81-6-4802-3533 |
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RD-clinical-information-Japan@astrazeneca.com |
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Ageishi Yuji |
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Astrazeneka K.K |
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3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka |
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+81-6-4802-3533 |
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RD-clinical-information-Japan@astrazeneca.com |
Not Recruiting |
Oct. 25, 2023 |
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Oct. 25, 2023 | ||
12 | ||
Interventional |
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randomized controlled trial |
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single blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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1 Participants must be 18 to 60 years of age inclusive, at the time of signing the informed consent. |
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1 As judged by the investigator, any evidence of any clinically important disease or disorder which, in the investigator's opinion makes it undesirable for the participant to participate in the study. |
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18age old over | ||
60age old under | ||
Both |
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nonalcoholic fatty liver disease |
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Each participant is expected to be in the study for approximately 23 weeks, including a Screening Period of up to 4 weeks, a 9 week Treatment Period, and a Follow up Period of 10 weeks. Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via SC injection. |
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To investigate the safety and tolerability of AZD7503 following SC administration of multiple doses in healthy Japanese participants. |
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Astrazeneca K.K |
Hakata Clinic Institutional Review Board | |
6-18, Tenyamachi, Hakata-ku, Fukuoka, Fukuoka | |
+81-92-283-7701 |
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Approval | |
No |
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NCT06093542 | |
ClinicalTrials.gov |
none |