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A Study of Subcutaneous DR-01 in Healthy Volunteers

NCT06766864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-29

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, and PD of SC administration of single ascending doses of DR-01 in healthy volunteers.

Conditions

  • Healthy Volunteer

Interventions

DRUG

DR-01

DR-01 is a monoclonal antibody

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Dren Bio

    lead INDUSTRY

Principal Investigators

  • Michael Rothenberg, MD, PhD · Dren Bio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2025-08-27
Completion
2025-08-27

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06766864 on ClinicalTrials.gov