A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry

NCT05351047 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: D6800C00002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of multiple ascending doses (MAD) of AZD2373 in healthy male participants of sub-Saharan West African ancestry.

Conditions

Healthy Volunteers

Keywords

Phase 1; Randomized; Single-blind; Placebo controlled; AZD2373; Multiple Ascending Dose

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events and/or abnormal findings in vital signs, and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or injection site reactions

  To assess the safety and tolerability of subcutaneous (SC) multiple ascending dose (MAD) administrations of AZD2373.

  Up to 21 weeks (From Screening to Final Visit)

Secondary Outcomes (8)

• AUCinf

  Up to 16 weeks (From Visit 2 to Final Visit)

• AUCt

  Up to 16 weeks (From Visit 2 to Final Visit)

• AUCτ

  Up to 16 weeks (From Visit 2 to Final Visit)

• Cmax

  Up to 16 weeks (From Visit 2 to Final Visit)

• tmax

  Up to 16 weeks (From Visit 2 to Final Visit)

Study Arms (5)

Cohort 1

EXPERIMENTAL

Once weekly dosing for 4 weeks (Dosing Days 1, 8, 15 and 22) OR Once weekly dosing for 6 weeks (Dosing Days 1, 8, 15, 22, 29 and 36) randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 1 (6 subjects) or matching placebo (2 subjects).

Drug: AZD2373 subcutaneous injection; Drug: Placebo

Cohort 2

EXPERIMENTAL

Once weekly for 6 weeks dosing on Days 1, 8, 15, 22, 29 and 36 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects).

Drug: AZD2373 subcutaneous injection; Drug: Placebo

Cohort 3

EXPERIMENTAL

Three times weekly for 6 weeks dosing each week on Days 1, 3, and 5 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects).

Drug: AZD2373 subcutaneous injection; Drug: Placebo

Cohort 4 (optional)

EXPERIMENTAL

Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects).

Drug: AZD2373 subcutaneous injection; Drug: Placebo

Cohort 5 (optional)

EXPERIMENTAL

Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects).

Drug: AZD2373 subcutaneous injection; Drug: Placebo

Interventions

AZD2373 subcutaneous injection DRUG

Randomized subjects will receive multiple ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5).

Cohort 1; Cohort 2; Cohort 3; Cohort 4 (optional); Cohort 5 (optional)

Placebo DRUG

Randomized subjects will receive a multiple ascending dose of placebo (saline solution) by SC injection.

Cohort 1; Cohort 2; Cohort 3; Cohort 4 (optional); Cohort 5 (optional)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male participants of sub-Saharan West African ancestry aged 18 to 55 years (inclusive, at time of informed consent)
• Have a BMI between 18.5 and 35 kg/m2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive) at screening.
• Provision of signed, written and dated informed consent and completed mandatory genotyping in the pre-screening study .

You may not qualify if:

• \. Participants with known ancestry outside of sub-Saharan West Africa.
• \. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
• \. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• \. History of any chronic skin disease, auto-immunological diseases and allergic diseases of any etiology.
• \. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks prior to administration of IMP on Study Day 1.
• \. Participant has clinical signs and symptoms consistent with SARS-CoV-2 or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
• Participant who had a severe course of COVID-19.
• \. Participant has a positive viral RNA test result for SARS-CoV-2 before randomization.
• \. Any laboratory values with the following deviations:
• ALT or AST greater than ULN and clinically significant as determined by the PI.
• WBC count \< 3.0 x 109/L.
• Hb below LLN.
• Total bilirubin \> ULN.
• Platelet count below LLN.
• , Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, as judged by the PI.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is single-blind (in which the study center staff remain blinded during the clinical conduct of a given cohort) with regard to treatment (AZD2373 or placebo) at each dose level. Study participants will be blinded to treatment allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 28, 2022
• Study Start: April 4, 2022
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

US (1)