A Study of ALPN-303 in Adult Healthy Volunteers

Sponsor

Alpine Immune Sciences, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05034484

Collaborator

(none)

Enrollment

Locations

Arms

7.5

Anticipated Duration (Months)

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 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 :

Nov 15, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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 matching ALPN-303 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 matching ALPN-303 will be administered

Outcome Measures

Primary Outcome Measures

Adverse Events [Day 1 through Day 29]
Type, incidence, and severity of adverse events as assessed by CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 6 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Brisbane	Queensland	Australia	4006
2	Investigative Site	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

Alpine Immune Sciences, Inc.

Investigators

Study Director: Pille Harrison, MD, Alpine Immune Sciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alpine Immune Sciences, Inc.

ClinicalTrials.gov Identifier:

NCT05034484

Other Study ID Numbers:

AIS-D01

First Posted:

Sep 5, 2021

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alpine Immune Sciences, Inc.

Healthy Volunteer

BAFF

APRIL

Study Results

No Results Posted as of Apr 4, 2022