NCT06259903

Subcutaneous Administration of MD-18 in Healthy Subjects

A Single Center, Single Dose, Double-blind, Randomized, Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in Healthy Subjects.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Cohen Global, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A Single Center, Single Dose, Double-blind, Randomized, Placebo-controlled Dose-Escalating Study to Evaluate Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in healthy subjects.

Detailed description

This study will be conducted as a single-center study. A single escalating dose of MD-18 will be administered to each subject with a seven-day follow-up. 35 subjects will be enrolled. Cohorts will receive doses of 40. 80, 160, 240 or 320 milligram of MD-18 using 5:2 (active: placebo) randomization. Sentinel dosing will be used, consisting of enrolling three subjects at a 2:1 active to placebo ratio followed by the remaining subjects in the respective dose cohorts enrolled 48 hours later. Each of the 5 dose cohorts will enroll five active and two placebo subjects, with a total of 25 subjects receiving active therapy across the 5 arms and 10 subjects receiving placebo. The study will be conducted on an in-patient basis for the first 24 hours, followed by discharge and telephone check-in at 48 and 72 hours and return for follow-up visit at 7 days after administration of a single dose of MD-18.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MD-18	Subcutaneous Administration of MD-18 in Healthy Subjects.

Timeline

• Start date: 2024-05-07
• Primary completion: 2024-12-01
• Completion: 2025-04-01
• First posted: 2024-02-14
• Last updated: 2024-10-01

Locations

1 site across 1 country: Israel