NCT04941989

A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562

A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Subcutaneous HTL0022562 in Healthy Adult Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Nxera Pharma UK Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

Detailed description

This is a first in human, two part, double blind, placebo controlled, randomised single and multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of HTL0022562. Part 1 comprises of 7 sequential ascending dosing cohorts and Part 2 comprises of 4 multiple ascending dosing cohorts.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HTL0022562	HTL0022562
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-05-25
• Primary completion: 2021-11-19
• Completion: 2021-11-19
• First posted: 2021-06-28
• Last updated: 2025-02-20

Locations

1 site across 1 country: United Kingdom