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A Study of ALPN-303 in Adult Healthy Volunteers (RUBY-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05034484
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Alpine Immune Sciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ALPN-303 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303 in Adult Healthy Volunteers
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: ALPN-303 Regimen A Drug: ALPN-303
Multiple dose levels will be evaluated.

Placebo Comparator: Placebo Regimen A Drug: Placebo
Placebo will be administered

Experimental: ALPN-303 Regimen B Drug: ALPN-303
Multiple dose levels will be evaluated.

Placebo Comparator: Placebo Regimen B Drug: Placebo
Placebo will be administered




Primary Outcome Measures :
  1. Treatment-emergent Adverse Events (TEAE) [ Time Frame: Day 1 through Day 30 ]
    Type, incidence, and severity of TEAE as assessed by CTCAE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Summary of Inclusion Criteria:

  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05034484


Contacts
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Contact: Anushka Paul 61 2 8052 4829 ALPN-303@georgeclinical.com

Locations
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Australia, Queensland
Investigative Site Recruiting
Brisbane, Queensland, Australia, 4006
Australia, Victoria
Investigative Site Recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Alpine Immune Sciences, Inc.
Investigators
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Study Director: Stanford Peng, MD PhD Alpine Immune Sciences, Inc.
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Responsible Party: Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier: NCT05034484    
Other Study ID Numbers: AIS-D01
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpine Immune Sciences, Inc.:
Healthy Volunteer
BAFF
APRIL