NCT05427253

First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects

A Double-blind, Placebo-controlled, Randomised, First in Human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of C106 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Vicore Pharma AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in healthy females of non-childbearing potential and healthy males. The trial will be conducted in 2 parts: Part A, single ascending dose (SAD) including a food interaction cohort: safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving single ascending doses of C106. Part B, multiple ascending dose (MAD): safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving twice daily multiple ascending doses of C106 for 8 days.

Conditions

• Safety Issues
• Tolerance
• Idiopathic Pulmonary Fibrosis
• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	C106 solution	selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist
DRUG	Placebo	Placebo for C106 solution

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2022-06-22
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

1 site across 1 country: Sweden