NCT04559971

A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers

A Randomised, Double-blind, Placebo-controlled Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SLN124 in Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Silence Therapeutics plc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.

Detailed description

This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN124 after single ascending s.c. doses in healthy male and female subjects. Up to 3 cohorts of 24 healthy volunteers will be enrolled. Each subject will receive a single dose of SLN124 or placebo given by subcutaneous (s.c) injection.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SLN124	SLN124 for subcutaneous (s.c.) injection
DRUG	Placebo	Sodium chloride for s.c. injection

Timeline

• Start date: 2020-09-03
• Primary completion: 2021-03-23
• Completion: 2021-03-23
• First posted: 2020-09-23
• Last updated: 2023-04-21

Locations

1 site across 1 country: United Kingdom