Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers
NCT05921591 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-09-28
Summary
The purpose of this clinical study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
IRL201104
Lyophilised powder for reconstitution for IV dosing
- DRUG
-
Matching placebo for IRL201104
Sponsors & Collaborators
-
Revolo Biotherapeutics
lead INDUSTRY
Principal Investigators
-
Anoshie Ratnayake, MD, MPH · Revolo Biotherapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-26
- Primary Completion
- 2023-09-12
- Completion
- 2023-09-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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