Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07868237
PHASE1

A Phase I Study to Investigate KH-001 in Healthy Males

Sponsor: Kadence Bio

View on ClinicalTrials.gov

Summary

This was a Phase I, first-in-human study of KH-001 besylate in healthy male participants, conducted to investigate the safety, tolerability and pharmacokinetics (PK) of the study drug. The study was conducted in three parts: a single ascending dose (SAD) part, a multiple ascending dose (MAD) part, and a Formulation Effect part evaluating an orodispersible tablet (ODT) formulation. The study also evaluated the effect of KH-001 besylate on suicidality risk and mood. KH-001 besylate is being developed as an on-demand oral treatment for premature ejaculation.

Official title: A Phase I, Randomised, Double-blind, Placebo-controlled First in Human Study to Assess the Safety and Pharmacokinetics of KH-001 Besylate in Healthy Male Participants

Key Details

Gender

MALE

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2023-11-14

Completion Date

2025-08-28

Last Updated

2026-10-09

Healthy Volunteers

Yes

Interventions

DRUG

KH-001 besylate

Associated arm(s): 1 and 3

DRUG

KH-001 besylate placebo

Associated arm(s): Arm 2 (Placebo)

Locations (1)

Simbec-Orion Clinical Pharmacology Unit

Merthyr Tydfil, South Wales, United Kingdom