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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05034484




Registration number
NCT05034484
Ethics application status
Date submitted
26/08/2021
Date registered
5/09/2021
Date last updated
9/05/2023

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
This study is to assess the safety, tolerability, pharmacokinetics (the amount of drug in the
blood), pharmacodynamics (how the drug effects the body) and immunogenicity (how the drug
effects the immune system) of a single dose of an investigational drug called ALPN-303.
Multiple dose levels will be tested.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05034484
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