NCT03748836

Adult Healthy Volunteers Study to Evaluate ALPN-101 Safety

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-101 in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Alpine Immune Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

AIS-A01 is a phase 1, randomized, placebo-controlled, double-blinded study in healthy volunteers. It will be conducted at a single center and will enroll approximately 104 participants. The study will have 2 parts: * In Part A, participants will receive a single dose of study drug or placebo. Multiple dose levels of ALPN-101 will be evaluated. * In Part B, participants will receive 4 doses of ALPN-101 or placebo--1 dose each week for 4 weeks. Multiple dose levels of ALPN-101 will be evaluated. In each Part, safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK and PD samples will be collected.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ALPN-101	Single or multiple doses of ALPN-101 delivered via intravenous or subcutaneous injection. Ascending dose levels will be evaluated.
DRUG	Placebo	Single or multiple doses of placebo delivered via intravenous or subcutaneous injection, matched to ALPN-101 cohorts.

Timeline

• Start date: 2019-01-29
• Primary completion: 2019-11-18
• Completion: 2019-11-18
• First posted: 2018-11-21
• Last updated: 2019-12-05

Locations

1 site across 1 country: Australia