Trial Review

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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] 311956 0
APG990-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 333553 0
Condition category
Condition code
Skin 330257 330257 0 0
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] 328429 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] 338003 0
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
Timepoint [1] 338003 0
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] 434088 0
Assessment of pharmacokinetics (PK) parameters: Cmax, Tmax, AUC0-last, AUC0-inf, Lambda-Z, t1/2, CL/F, Vz/F
Timepoint [1] 434088 0
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] 434089 0
Number of participants with anti-drug antibodies (ADA)
Timepoint [2] 434089 0
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] 434090 0
Cmax and AUC in participants with and without ADA
Timepoint [3] 434090 0
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
40
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316295 0
Commercial sector/Industry
Name [1] 316295 0
Apogee Therapeutics, Inc.
Country [1] 316295 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] 318790 0
None
Name [1] 318790 0
Address [1] 318790 0
Country [1] 318790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315115 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 315115 0
Ethics committee country [1] 315115 0
Australia
Date submitted for ethics approval [1] 315115 0
05/06/2024
Approval date [1] 315115 0
15/07/2024
Ethics approval number [1] 315115 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133718 0
Dr Kristi McLendon
Address 133718 0
Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, Queensland, 4006
Country 133718 0
Australia
Phone 133718 0
+61 07 3707 2720
Fax 133718 0
Email 133718 0
[email protected]
Contact person for public queries
Name 133719 0
Nucleus Network Brisbane
Address 133719 0
Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, QLD 4006
Country 133719 0
Australia
Phone 133719 0
+61 1800 243 733
Fax 133719 0
Email 133719 0
[email protected]
Contact person for scientific queries
Name 133720 0
Nucleus Network Brisbane
Address 133720 0
Nucleus Network Brisbane, Level 5, 300C Herston Road, Herston, QLD 4006
Country 133720 0
Australia
Phone 133720 0
+61 1800 243 733
Fax 133720 0
Email 133720 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
No additional documents have been identified.