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Trial registered on ANZCTR

Registration number

ACTRN12624000775516

Ethics application status

Approved

Date submitted

10/06/2024

Date registered

25/06/2024

Date last updated

3/10/2024

Date data sharing statement initially provided

25/06/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

A First-in-human Study of APG990 in Healthy Participants

Scientific title

A Phase 1, Randomized, Blinded, Placebo-controlled, Single Ascending Dose, First-in-human Study of the Safety, Tolerability, and Pharmacokinetics of APG990 in Healthy Participants

Secondary ID [1]

APG990-101

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atopic Dermatitis

Condition category

Condition code

Skin

Dermatological conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will evaluate single ascending doses (SAD) of APG990 administered subcutaneously (SC) in healthy participants. In each of 5 treatment cohorts (maximum), 8 participants will be randomized 6:2 to APG990 or placebo (up to 40 participants total).

Cohort 1 - APG990 Dose 75 milligram (mg) or placebo
Cohort 2 - APG990 Dose 150 mg or placebo
Cohort 3 - APG990 Dose 300 mg or placebo
Cohort 4 - APG990 Dose 600 mg or placebo
Cohort 5 - APG990 Dose 1200 mg or placebo

The study will be conducted at a single site in Australia. The anticipated duration of the study is up to approximately 267 days, including screening and safety follow-up. This is a single dose study. The study drug will be administered in the clinical research unit (CRU) by qualified/trained study staff. Any issues or deviations that occur during dosing will be reported to the Sponsor as soon as feasibly possible.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo (0.9% sodium chloride) solution will be administered via SC injection.

Control group

Placebo

Outcomes

Primary outcome [1]

Incidence of treatment-emergent adverse events (TEAEs) coded based on the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Assessment method [1]

TEAEs (including those leading to discontinuation of study drug): via interviews (one-on-one, face-to-face interview with a member of the research team), physical examinations and review of clinical safety laboratory test results and ECG reports. The Investigator or designee will review each event (including injection site reactions) and assess its severity based on the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting selfcare activities of daily living; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE. Clinical safety laboratory findings- Serum chemistry (including liver function tests, electrolytes, and kidney function tests), full blood count and coagulation tests will be assessed using whole blood samples; urinalysis will be assessed using urine samples. Vital signs will be measured on the arm opposite any IV canulae. Incidence of clinically significant laboratory findings will be reported as adverse events. Vital signs to be assessed include heart rate through stethoscope, blood pressure through digital sphygmomanometer, body temperature, and respiratory rate. clinical research unit (CRU) standard ranges will be used for determining clinical significance. Number of participants with TEAEs, clinically significant laboratory values, abnormal vital sign values, ECG values and abnormal physical examination findings will be assessed and reported collectively.

Timepoint [1]

Day 1: 0- (pre-dose), 4-, 8-, 24-, 48-, and 72- hours post-dose and on Days 8, 11, 15, 22, 29, 57, 85, 113, 141, 169, 197, and 225 post-dose

Secondary outcome [1]

Assessment of pharmacokinetics (PK) parameters: Cmax, Tmax, AUC0-last, AUC0-inf, Lambda-Z, t1/2, CL/F, Vz/F

Timepoint [1]

Day 1: 0- (pre-dose), 4-, 8-, 24-, 48-, and 72- hours post-dose and on Days 8, 11, 15, 22, 29, 57, 85, 113, 141, 169, 197, and 225 post-dose

Secondary outcome [2]

Number of participants with anti-drug antibodies (ADA)

Timepoint [2]

Day 1: 0-hours (pre-dose) and on Days 15, 22, 29, 57, 85, 113, 141, 169, 197, and 225 post-dose

Secondary outcome [3]

Cmax and AUC in participants with and without ADA

Timepoint [3]

Day 1: 0- (pre-dose), 4-, 8-, 24-, 48-, and 72-hours post-dose and on Days 8, 11, 15, 22, 29, 57, 85, 113, 141, 169, 197, and 225 post-dose

Eligibility

Key inclusion criteria

1. Healthy men and women, in the opinion of the Investigator and as determined by physical examination, laboratory screening tests, and medical history
2. 18 to 65 years of age (inclusive) with a body mass index of 18.0 to 32.0 kilogram per square meter (kg/m^2) (inclusive), weight less than (<) 120 kilogram (kg)
3. Willing to use a highly effective method of contraception from 30 days prior to admission through 30 days after end of study (EOS) or 5 half-lives after the last administration of study drug, whichever is longer
4. Willing to abstain from alcohol and tobacco use for 48 hours prior to admission to the CRU (Day -1) and during inpatient period, and any illicit drug abuse for greater than or equal to (>=) 48 hours prior to admission to the CRU (Day -1)

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Evidence of clinically significant abnormalities or disease
2. History of any of the following:
a. Clinically significant opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia) within 5 years prior to Screening
b. Serious local infection (eg, cellulitis) or systemic infection (eg, septicemia) within 3 months prior to Screening
3. Known history of illicit drug abuse, harmful alcohol use (defined as an average of >10 standard drinks per week or at the Investigator’s discretion) or alcoholism, and/or heavy tobacco use (defined as >=5 cigarettes per day or equivalent) within 2 years prior to Screening; positive screen for drugs of abuse (except tetrahydrocannabinol [THC]), or alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking for the duration of their stay in the CRU. Participants may be rescreened for drugs of abuse or alcohol breath test at the Investigator’s discretion
4. History of severe allergic reactions or hypersensitivity (ie, anaphylaxis)
5. If female, nursing, lactating, pregnant, or plans to become pregnant within 30 days of EOS or 5 half-lives (whichever is longer) of last study drug administration
6. 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
7. Use of any depot injection or implant for 3 months prior to dosing

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will occur via Randomization and Trial Supply Management (RTSM) System by an unblinded pharmacist.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomization.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

12/08/2024

Actual

15/08/2024

Date of last participant enrolment

Anticipated

28/02/2025

Actual

Date of last data collection

Anticipated

30/11/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Apogee Therapeutics, Inc.

Address [1]

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Apogee Therapeutics, Inc.

Address

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee

Ethics committee address [1]

123 Glen Osmond Rd, Eastwood SA 5063 (https://bellberry.com.au/)

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/06/2024

Approval date [1]

15/07/2024

Ethics approval number [1]

Summary

Brief summary

The main aim of the study is to evaluate the safety and tolerability of single doses of APG990 in healthy participants. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as atopic dermatitis, which is the anticipated main therapeutic use for APG990.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kristi McLendon

Address

Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, Queensland, 4006

Country

Australia

Phone

+61 07 3707 2720

Fax

[email protected]

Contact person for public queries

Name

Nucleus Network Brisbane

Address

Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, QLD 4006

Country

Australia

Phone

+61 1800 243 733

Fax

[email protected]

Contact person for scientific queries

Name

Nucleus Network Brisbane

Address

Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, QLD 4006

Country

Australia

Phone

+61 1800 243 733

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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