NCT04999527

Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects Following Dose-Escalating Single Intravenous or Subcutaneous Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Disc Medicine, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult healthy volunteers.

Detailed description

Enrolled participants in this study will receive a single dose of DISC-0974 or a placebo. Samples will be collected to measure how DISC-0974 is processed by the body and how the body responds when exposed to DISC-0974. Participants will receive a single study drug dose on Day 1; and follow-up for 10 weeks (71 days). If an undetectable DISC-0974 blood concentration is observed, the duration of follow-up will be shortened to 7 days thereafter, as feasible.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	DISC-0974	DISC-0974 is administered (IV infusion or Subcutaneous Injection) as a single dose
DRUG	Placebo	Placebo is administered (IV infusion or Subcutaneous Injection) as a single dose

Timeline

• Start date: 2021-08-10
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-08-11
• Last updated: 2022-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study