NCT03847207

A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310

A Three-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of HTL0030310 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Nxera Pharma UK Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, first in human, three-part, single centre study to assess the safety, tolerability, PK and PD of single ascending subcutaneous doses of HTL0030310 in healthy subjects

Detailed description

This is a first in human, three part study with the objective to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of HTL0030310 in healthy subjects. Part 1 is a double-blind, placebo-controlled, randomised study assessing single ascending doses of HTL0030310. Part 2 is a site-blind (sponsor unblinded), placebo-controlled, part-randomised, fixed-sequence, single-dose, 4-period study assessing the PD of a positive control, pasireotide, following administration of challenge agents. Part 3 is a double-blind, placebo-controlled, part-randomised, fixed-sequence, single-dose, HTL0030310 proof of pharmacological effect study, where PD effects of HTL0030310 will be investigated following administration of challenge agents. The challenge agents administered in this study will be: oral glucose tolerance test (OGTT), Growth hormone-releasing hormone (GHRH), and corticotrophin releasing hormone (CRH) combined with desmopressin.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HTL0030310	Solution for Subcutaneous injection
DRUG	Pasireotide	Pasireotide 600 μg for subcutaneous injection
DRUG	Placebo	Matching placebo Solution

Timeline

• Start date: 2019-01-23
• Primary completion: 2020-03-05
• Completion: 2020-03-05
• First posted: 2019-02-20
• Last updated: 2025-02-19

Locations

1 site across 1 country: United Kingdom