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

NCT05427253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-01-31

Study results available
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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

Interventions

DRUG

C106 solution

selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist

DRUG

Placebo

Placebo for C106 solution

Sponsors & Collaborators

  • Vicore Pharma AB

    lead INDUSTRY

Principal Investigators

  • Måns Jergil, PhD · CTC Clinical Trial Consultants AB (CTC)

  • Helena Litorp, MD, PhD · CTC Clinical Trial Consultants AB (CTC)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05427253 on ClinicalTrials.gov