NCT02958982

Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals

A Phase I/IIa, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, and Pharmacokinetics of Single and Multiple Ascending Dose of RP3128 in HV and Effect on LAR to Allergen Challenge in Mild Asthmatics

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending dose(s) of RP3128 in healthy volunteers and to evaluate the effect on late phase asthmatic response to allergen challenge in patients with mild asthma.

Detailed description

The study consists of three parts; Part 1: single ascending dose (SAD), Part 2: multiple ascending dose (MAD) in healthy volunteers and Part 3: proof of concept (POC) study in mild asthmatics. There will be 5 cohorts in SAD and 3 cohorts in MAD, the doses used in the MAD will be based on emerging safety, tolerability and pharmacokinetics (PK) from Part 1 (SAD). POC is a randomized, placebo- controlled, double blind, two period cross-over, proof of concept study in male and female of non child bearing potential with history of mild asthma. the highest identified dose of RP3128 in Part 2 (MAD) will be considered for POC

Conditions

• Healthy Volunteers
• Asthma

Interventions

Type	Name	Description
DRUG	RP3128	Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC
DRUG	Placebo	Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC

Timeline

• Start date: 2016-11-03
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-11-08
• Last updated: 2019-10-04
• Results posted: 2019-10-04

Locations

1 site across 1 country: Canada