A First-in-human Study of APG777 in Healthy Participants

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose, First-in-human Study of the Safety, Tolerability, and Pharmacokinetics of APG777 in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000786695

Enrollment

Registered

2023-07-19

Start date

2023-07-31

Completion date

2024-02-23

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of APG777 following single and multiple subcutaneous (SC) administration to healthy participants.

Interventions

IP Name: APG777 Treatment: Drug – APG777 Treatment Drug – Placebo Single ascending dose (SAD) Cohorts 1. Cohort 1: APG777 (Low dose) or Placebo - Participants will receive single subcutaneous (SC) injection of low dose (300 mg) of APG777 or placebo 2. Cohort 2: APG777 (Medium dose) or Placebo – Participants will receive single subcutaneous injection of medium dose (600 mg) of APG777 or placebo 3. Cohort 3: APG777 (High dose) or Placebo - Participants will receive single subcutaneous injection of high dose (1200 mg) of APG777 or placebo Study drug will be administered as a subcutaneous (SC) injection by trained personnel at the clinical research unit (CRU) and administration will be noted in patient medical records. Multiple dose (MD) Cohorts 1. Cohort 1: Participants will receive 300 mg of APG777 or placebo by subcutaneous injection on Day 1 and Day 29 2. Cohort 2: Participants will receive 300 mg of APG777 or placebo by subcutaneous injection on Day 1 and Day 15 Study drug will be administered as a SC injection by trained personnel at the CRU. The first MD cohort will be enrolled after the SRC has reviewed a minimum of 14 days post dose (Day 15) of safety and PK data from the SAD cohort. Approval of the MD part of the study is subject to HREC submission and approval.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

• Healthy men and women, as determined by physical examination, laboratory screening tests, and medical history • Body mass index (BMI) of 18 to 35 kg/m2 (inclusive), weight less than 120 kg • Willing to use a highly effective method of contraception from admission through 12 months or 5 half-lives, whichever is longer, after the last administration of study drug

Exclusion criteria

• Evidence of clinically significant abnormalities or disease, including, but not limited to, a) Hemoglobin A1c more than or equal to 6.5% and/or diagnosis of diabetes mellitus; b) Positive test for human immunodeficiency virus (HIV) antibody; c) Acute or chronic hepatitis B or C; d) Diagnosis or suspected diagnosis of immunodeficiency or autoimmune diseases, or undergoing immunosuppressive therapy; d) Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases and malignancies, as determined by the Investigator • History of severe allergic reactions or hypersensitivity (ie, anaphylaxis) • Known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs or antibody fragments, or to any components of the formulation of APG777 and its excipients used in this study • If female, nursing, lactating, pregnant. or plans to become pregnant within 12 months or 5 half-lives (whichever is longer) of last study drug administration • Use of any prescription or non-prescription medication 48 hours prior to dosing (exception: contraceptives or acetaminophen/paracetamol up to 2 g per day prior to dosing is permitted). • Vaccination within 14 days prior to administration of APG777 • Use of any investigational drug therapy within 30 days or 5 half-lives (whichever is longer) prior to study drug dosing through 5 half-lives after the last dose of study drug

Outcome results