NCT03036865

Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects

A Double-blind, Phase 1, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Boston Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy adult male and female participants.

Detailed description

Study BOS161721-01 will consist of 7 single ascending dose (SAD) cohorts, each with 8 participants (6 active:2 placebo), and an eighth SAD cohort with 5 participants (all active). Participants will be randomized in a 3:1 ratio (BOS161721:placebo) and will either receive a single dose of BOS161721 (1, 3, 10, 22, 30, 60, 120, or 240 milligrams \[mg\]) or placebo. Participants in Cohort 1 will receive the lowest dose, administered IV (1 mg), followed by Cohort 2, in which participants will receive the second lowest dose, administered SC (3 mg). BOS161721 or placebo will also be administered SC in Cohorts 3, 4, 5, 7, and 8. Participants in Cohort 6 will be administered an IV dose of 22 mg (5 active) in parallel to the 60 mg SC-dosed fifth cohort. This dose has been selected to generate a similar exposure to that following the 30 mg SC dose. The actual Cohort 6 IV dose may be adjusted upon available PK data. Participants will be in this study for up to 56 weeks, which includes a Screening Period of up to 28 days, a single-dose treatment day (during the in-subject treatment period), and a 52-week post-treatment Follow-up Period, which is required due to the potential half-life of BOS161721.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BOS161721	Single dose administered IV or SC
DRUG	Placebo	Single dose administered IV or SC

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-04-27
• Completion: 2018-04-27
• First posted: 2017-01-30
• Last updated: 2020-11-18

Locations

1 site across 1 country: United States