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A First-in-Human Study Evaluating AGA2118 in Men and Postmenopausal Women

NCT05225857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-05

No results posted yet for this study

Summary

The primary objectives of the study are to assess the safety and tolerability of AGA2118 after single subcutaneous or intravenous administration in healthy men and postmenopausal women and to assess the safety and tolerability of AGA2118 after multiple subcutaneous administrations in men and postmenopausal women.

Conditions

Interventions

DRUG

AGA2118

Part 1 - SAD study: SAD participants in various cohorts will receive various single dose of AGA2118 via either SC or IV. Part 2 - MAD study: MAD participants in various cohorts will receive various multiple doses of AGA2118 Q4W via SC.

DRUG

Placebo

Part 1 - SAD study: SAD participants in various cohorts will receive a single dose of placebo via either SC or IV. Part 2 - MAD study: MAD participants in various cohorts will receive multiple doses of placebo via SC.

Sponsors & Collaborators

  • Angitia Australia Pty Ltd

    collaborator INDUSTRY

  • Angitia Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Angitia Medical Director · Angitia Incorporated Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2024-01-13
Completion
2024-01-13

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225857 on ClinicalTrials.gov