Adult Healthy Volunteers Study to Evaluate ALPN-101 Safety

NCT03748836 | Completed Phase 1 DMC

• 1 other identifier: AIS-A01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing the safety, tolerability, pharmacokinetics (PK--the amount of study drug in the blood), pharmacodynamics (PD), how the study drug affects the body) and immunogenicity (how the study drug affects the immune system) of single and multiple doses and dose levels of an investigational drug called ALPN-101.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety, as assessed by adverse events according to CTCAE v5.0

  The rate of adverse events will be compared between the 2 treatment groups.

  From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4-8 weeks)

Secondary Outcomes (4)

• Pharmacokinetics of ALPN-101 as assessed by time of maximum ALPN-101 concentration.

  From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)

• Pharmacokinetics of ALPN-101 as assessed by the maximum concentration of ALPN-101.

  From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)

• Pharmacokinetics of ALPN-101 as assessed by AUC on all subjects.

  From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)

• The incidence of ADA against ALPN-101 will be assessed and summarized.

  From study Day 1 (dosing of ALPN-101 or placebo) until the End of Study visit (approx. 4 weeks for Part A of the study, and approx 6 weeks for Part B)

Study Arms (4)

Single Ascending Dose ALPN-101

ACTIVE COMPARATOR

Drug: ALPN-101

Single Dose Placebo

PLACEBO COMPARATOR

Drug: Placebo

Multiple Ascending Dose ALPN-101

ACTIVE COMPARATOR

Drug: ALPN-101

Multiple Dose Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALPN-101 DRUG

Single or multiple doses of ALPN-101 delivered via intravenous or subcutaneous injection. Ascending dose levels will be evaluated.

Multiple Ascending Dose ALPN-101; Single Ascending Dose ALPN-101

Placebo DRUG

Single or multiple doses of placebo delivered via intravenous or subcutaneous injection, matched to ALPN-101 cohorts.

Multiple Dose Placebo; Single Dose Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to participate and willing to give written informed consent.
• Healthy adult participant 18 to 65 years of age, inclusive, at the time of informed consent.
• BMI between 18 and 30 kg/m2, inclusive.
• Male participants must agree to use a highly effective method of contraception consistently and correctly during the treatment period and for at least 30 days after the last dose of study intervention and to refrain from donating sperm during this period.
• Female participants must not be pregnant or breastfeeding

You may not qualify if:

• Any concomitant disease, condition or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
• History or symptoms of significant psychiatric disease in the opinion of the Principal Investigator, including but not limited to depression and schizophrenia.
• History of immunological disorders, auto-immune disorders, acquired or congenital immune deficiency.
• 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, except for the following, which did not require systemic therapy and are considered cured: nonmelanoma skin cancer, curatively treated localised prostate cancer or other in situ cancer.
• Use of prescription medications or herbal remedies within 14 days or 5 elimination half-lives (whichever is longer) of study intervention administration or use of over-the-counter medications (OTC) within 7 days of study intervention administration (apart from recommended doses of vitamin/mineral supplements, OTC analgesics, etc., approved by the Investigator and Sponsor). Participants who have been on hormone replacement therapy (HOURST) for a period of at least 2 months will not be excluded from the study, provided the HOURST regimen remains unchanged during the conduct of the study.
• Any concomitant medications that prolong QT/QTc interval.
• Dosed with an investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to study drug administration.
• Received any systemic steroid within 1 month or systemic immunosuppressant agent within 6 months prior to study drug administration.
• Received any antibody therapy or biologic products within 6 months prior to study drug administration.
• Significant loss of blood including blood donation over 500 mL or transfusion of any blood product within 3 months before the Screening Visit.
• Unwilling to refrain alcohol use 48 hours prior to your admission into the clinical research unit.
• Known hypersensitivity, allergy or intolerance to the study drug or any of the excipient contained in the intervention formulation.
• Immunisation with any vaccine within 6 weeks prior to study drug administration.
• Any clinically significant (at the discretion of the Investigator) abnormalities in laboratory test results, including complete blood count, chemistry panels and urinalysis. If out of range at the Screening Visit and/or admission to the CRU and deemed clinically significant by investigator, the tests may be repeated once on a separate day.

Sponsors & Collaborators

• Alpine Immune Sciences, Inc.: lead
• Clinical Network Services (CNS) Pty Ltd: collaborator

Study Sites (1)

Nucleus Network- Centre for Clinical Studies

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Interventions

ALPN-101

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded, placebo-controlled
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of single and multiple doses of ALPN-101

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 21, 2018
• Study Start: January 29, 2019
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)