A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers
NCT06008652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-08-13
Summary
This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy volunteers.
Conditions
- Healthy Adult Volunteers
Interventions
- DRUG
-
DR-0201
DR-0201 is a bi-specific antibody
- DRUG
-
Placebo
Sponsors & Collaborators
-
Novotech
collaborator UNKNOWN -
Dren Bio
lead INDUSTRY
Principal Investigators
-
Matthias Will, MD · Dren Bio
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-26
- Primary Completion
- 2024-07-24
- Completion
- 2024-07-24
Countries
- Australia
Study Locations
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