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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05034484




Registration number
NCT05034484
Ethics application status
Date submitted
26/08/2021
Date registered
5/09/2021

Titles & IDs
Public title
A Study of ALPN-303 in Adult Healthy Volunteers
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303 in Adult Healthy Volunteers
Secondary ID [1] 0 0
AIS-D01
Universal Trial Number (UTN)
Trial acronym
RUBY-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALPN-303
Treatment: Drugs - Placebo

Experimental: ALPN-303 Regimen A -

Placebo comparator: Placebo Regimen A -

Experimental: ALPN-303 Regimen B -

Placebo comparator: Placebo Regimen B -


Treatment: Drugs: ALPN-303
Multiple dose levels will be evaluated.

Treatment: Drugs: Placebo
Placebo will be administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-emergent Adverse Events (TEAE)
Timepoint [1] 0 0
Day 1 through Day 30

Eligibility
Key inclusion criteria
Summary of

* Able and willing to provide written informed consent
* Body mass index 18 to 32 kg/m2
* Agree to avoid strenuous physical activity for 2 days prior to each study visit
* Agree to use highly effective contraception during the study (all participants) and for 90 days after study drug dosing (males) or for 60 days after study drug dosing (females)
* Male participants must refrain from donating sperm during the study and for 90 days after study drug dosing
* Female participants must not be pregnant or breastfeeding and must refrain from donating ova during the study and for 60 days after study drug dosing
* Must have completed vaccination against SARS-CoV-2 at least 4 weeks prior to study drug dosing

Summary of
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any current disease, condition, or treatment that could interfere with the study, interfere with interpretation of the data, or pose an unacceptable risk to the participant
* History or symptoms of significant psychiatric disease; mild, resolved depression or anxiety is acceptable
* History of immunological disorders, auto-immune disorders, acquired or congenital immune deficiency; see protocol for clarifications/exceptions
* History of significant hepatic or renal disease or impairment
* Evidence of an active or suspected cancer or a history of malignancy within the previous 3 years; see protocol for exceptions
* History of major organ transplantation with an existing functional graft
* Use or receipt of prescription medications, over-the-counter medications, herbal remedies, or investigation products (study drugs) within protocol-defined timeframes prior to study entry; hormone replacement therapy initiated at least 2 months prior to Screening is acceptable
* Significant loss of blood or blood product (including donation) over 500 mL or transfusion of any blood product during Screening or within 3 months of Screening
* Unwilling to refrain from alcohol use = 48 hours prior to Study Day -1.
* Known hypersensitivity, allergy, or intolerance to ALPN-303, Fc-based biologic therapy, or any of the excipients contained in the ALPN-303 formulation
* Immunization with any live vaccine within 6 weeks prior to study drug administration, or expected to require any live vaccines during the study or within 6 weeks after receiving study drug
* Acceptable laboratory assessments at Screening and Day -1
* Positive screen for drugs of abuse or alcohol at Screening or Day -1
* Positive tests for infectious disease (HIV, hepatitis B, hepatitis C, SARS-CoV-2)
* Acute infection during or within 4 weeks prior to Screening
* History of frequent or atypical infections as defined per protocol; signs or symptoms of immunodeficiency
* History or presence of any chronic infectious condition
* Cardiac risk factors, as defined per protocol

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/02/2023
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Investigative Site - Brisbane
Recruitment hospital [2] 0 0
Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alpine Immune Sciences, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Stanford Peng, MD PhD
Address 0 0
Alpine Immune Sciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05034484