NCT06050915

A Study of DISC-3405 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Characteristics of DISC-3405 in Adult Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Disc Medicine, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This phase 1 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of DISC-3405 in adult male and female healthy volunteers.

Detailed description

Each enrolled subject will receive one single or multiple doses of DISC-3405 or placebo. During the study, subjects will be evaluated for safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of DISC-3405. In the single ascending dose (SAD) phase, a sentinel group of two subjects will be dosed first: one with DISC-3405, and the other with placebo; the randomization and blinding will be maintained. The remaining subjects for the cohort will be dosed at least 24 hours after the last sentinel dosing following approval from the principal investigator. Subsequent multiple ascending dose (MAD) cohorts will only enroll after a sufficient safety observation period for the SAD cohort, accordingly there will be no sentinel participants for cohorts in MAD. DISC-3405 or placebo will be administered as an IV infusion or subcutaneous injection. Subjects will have end-of-study (EOS) follow-up visits on Day 99 after the last administration.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	DISC-3405	DISC-3405 is administered as a single dose IV infusion or subcutaneous injection
DRUG	DISC-3405	DISC-3405 is administered in multiple ascending doses as an IV infusion or subcutaneous injection
DRUG	Placebo	Placebo is administered as a single dose IV infusion or subcutaneous injection
DRUG	Placebo	Placebo is administered in multiple ascending doses as an IV infusion or subcutaneous injection

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2023-09-22
• Last updated: 2024-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study