A Study of ALPN-303 in Adult Healthy Volunteers

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Regimen A	Placebo	-
ALPN-303 Regimen B	ALPN-303	-
ALPN-303 Regimen A	ALPN-303	-
Placebo Regimen B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events (TEAE)	Day 1 through Day 30	Type, incidence, and severity of TEAE as assessed by CTCAE

Secondary Outcome Measures

Name	Time	Method

A Study of ALPN-303 in Adult Healthy Volunteers

Recruitment & Eligibility

Study & Design

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