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Trial registered on ANZCTR


Registration number
ACTRN12624001358538p
Ethics application status
Submitted, not yet approved
Date submitted
15/10/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A first-in-human study of APG333 in healthy participants
Scientific title
A phase 1, randomized, blinded, placebo-controlled, first-in-human study of the safety, tolerability, and pharmacokinetics of single ascending doses of APG333 in healthy participants
Secondary ID [1] 313109 0
APG333-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 335356 0
Chronic obstructive pulmonary disease 335368 0
Condition category
Condition code
Respiratory 331943 331943 0 0
Chronic obstructive pulmonary disease
Respiratory 332159 332159 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate single ascending doses (SAD) of APG333 administered subcutaneously (SC) in healthy participants. In each of 4 treatment cohorts (maximum), 8 participants will be randomized 6:2 to APG333 or placebo (up to 32 participants total).

Cohort 1 - APG333 Dose 125 milligram (mg) or placebo
Cohort 2 - APG333 Dose 250 mg or placebo
Cohort 3 - APG333 Dose 500 mg or placebo
Cohort 4 - APG333 Dose 1000 mg or placebo

The study will be conducted in Australia. The anticipated duration of the study is up to approximately 267 days, including screening and safety follow-up.
Intervention code [1] 329678 0
Treatment: Drugs
Comparator / control treatment
Placebo (0.9% sodium chloride) solution will be administered via SC injection.
Control group
Placebo

Outcomes
Primary outcome [1] 339548 0
Incidence of treatment-emergent adverse events (TEAEs) coded using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Timepoint [1] 339548 0
Collection of AEs, physical examinations, and assessment of vital signs performed on Day 1: 0-hours (pre-dose), 4-, 8-, 24-, 48-, and 72-hours post-dose and on Days 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, and 225 post-dose.
ECGs performed on Day 1: 0-hours (pre-dose) and on Days 15, 22, 29, 85, 169, 197, and 225 post-dose.
Clinical safety laboratory tests performed Day 1: 4-, 24- ,48-, 72-hours post-dose, and on Days 8, 22, 29, 57, 85, 113, 141, 169, 197, and 225 post-dose.
Secondary outcome [1] 440404 0
Assessment of pharmacokinetics (PK) parameters: Cmax, tmax, AUC0-last, AUC0-inf, Lambda-Z, t1/2, CL/F, Vz/F
Timepoint [1] 440404 0
Day 1: 0-hours (pre-dose), 4-, 8-, 24-, 48-, and 72- hours post-dose and on Days 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, and 225 post-dose
Secondary outcome [2] 440405 0
Number of participants with anti-drug antibodies (ADA)
Timepoint [2] 440405 0
Day 1: 0-hours (pre-dose) and on Days 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 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 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, tobacco, and illicit drug use for 48 hours prior to admission to the CRU (Day -1) and during the inpatient period.
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. 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 system infection (eg, septicemia) within 3 months prior to Screening
2. 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 excessive tobacco use (defined as >=5 cigarettes or e-cigarette equivalent [0.5 mL e cigarette fluid equivalent to 5 cigarettes] per day) within 2 years prior to Screening; positive screen for drugs of abuse (except tetrahydrocannabinol [THC]), or positive alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking and vaping 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
3. History of severe allergic reactions or hypersensitivity (ie, anaphylaxis)
4. If female, nursing, lactating, pregnant, or plans to become pregnant within 30 days of EOS or 5 half-lives (whichever is longer) of study drug administration
5. Use of any prescription or nonprescription medication 7 days prior to dosing through CRU discharge Day 4 (exception: contraceptives, hormone replacement therapy, vitamins, over-the-counter [OTC] antihistamines, OTC topical steroids, or acetaminophen/paracetamol up to 2 gram (g) per day prior to dosing is permitted)
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

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 Interactive Response Technology (IRT) 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
Not yet recruiting
Date of first participant enrolment
Anticipated
9/12/2024
Actual
Date of last participant enrolment
Anticipated
3/04/2025
Actual
Date of last data collection
Anticipated
13/11/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317553 0
Commercial sector/Industry
Name [1] 317553 0
Apogee Therapeutics, Inc.
Country [1] 317553 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Apogee Therapeutics, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 319859 0
None
Name [1] 319859 0
Address [1] 319859 0
Country [1] 319859 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316264 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 316264 0
123 Glen Osmond Rd, Eastwood SA 5063 (https://bellberry.com.au/)
Ethics committee country [1] 316264 0
Australia
Date submitted for ethics approval [1] 316264 0
02/10/2024
Approval date [1] 316264 0
Ethics approval number [1] 316264 0

Summary
Brief summary
The main aim of the study is to test the safety, tolerability, pharmacokinetics, and immunogenicity of a single dose of APG333. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as asthma and chronic obstructive pulmonary disease, which is the anticipated main therapeutic use for APG333.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137330 0
Dr Michael Wong
Address 137330 0
Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, QLD 4006
Country 137330 0
Australia
Phone 137330 0
+61 07 3707 2720
Fax 137330 0
Email 137330 0
[email protected]
Contact person for public queries
Name 137331 0
Nucleus Network Brisbane
Address 137331 0
Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, QLD 4006
Country 137331 0
Australia
Phone 137331 0
+61 1800 243 733
Fax 137331 0
Email 137331 0
[email protected]
Contact person for scientific queries
Name 137332 0
Nucleus Network Brisbane
Address 137332 0
Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, QLD 4006
Country 137332 0
Australia
Phone 137332 0
+61 1800 243 733
Fax 137332 0
Email 137332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
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