A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults

JRCT ID: jRCT2071230040

Registered date:12/07/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19, SARS-CoV-2
• Date of first enrollment: 31/07/2023
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Healthy participants will be randomised in each cohort to either AZD3152 or placebo administered IM or IV, across 3 fixed-dose cohorts.

Outcome(s)

Primary Outcome

- To evaluate the safety and tolerability of AZD3152 administered IM or IV to healthy adult participants 18 to 55 years of age.

- To characterise the serum PK of AZD3152 after single IM or IV administration of AZD3152.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

- Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.

- No positive results of SARS-CoV-2 NAT and/or rapid antigen tests.

- Healthy participants by medical history, physical examination, baseline safety laboratory studies, and screening parameters, according to the judgement of the investigators, with no concomitant disease or concomitant medication.

- ECG without clinically significant abnormalities.

- Able to complete the Follow-up Period through Day 361 as required by the protocol.

- Body weight 45 kg or more and 110 kg or less and BMI 18.0 or more to 30.0 kg/m2 or less.

Exclude criteria

- Known hypersensitivity to any component of the IMP.

- History of allergic disease or reactions likely to be exacerbated by any component of the IMP.

- Previous hypersensitivity, infusion related reaction or severe adverse reaction following administration of mAbs.

- Fever above 38.0 degrees celsius on day prior to or on day of randomisation/dosing.

- AST, ALT or serum creatinine above ULN; bilirubin and ALP >1.5 x ULN.

- Any vaccination except for COVID-19 vaccine (e.g., inactivated influenzae vaccine) planned.

- SARS CoV-2 or COVID-19:

Receipt of a COVID-19 vaccine within 3 months. COVID-19 infection within 3 months prior.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05932641