Study of BB-025, Alone and After BB-031, in Healthy Volunteers
NCT07202663 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2026-04-06
Summary
The goal of this 2-part clinical trial is to learn about the safety and pharmacokinetics (PK) of a single dose of BB-025 when given on its own and after being given BB-031. Researchers will compare BB-025 to placebo (a look-alike substance that contains no drug) both on its own and after being given a single dose of BB-031 to assess the use of BB-025 as a reversal agent.
In the first part of the study, participants will receive a single dose of BB-025 or placebo. They will be followed for 28 days to check if they have any symptoms.
In the second part of the study, participants will receive a single dose of BB-031 and then be given either BB-025 or placebo. These participants will also be followed for 28 days to check if they have any symptoms.
Conditions
- Pharmacodynamics
- Pharmacokinetics
- Healthy Volunteers
Interventions
- DRUG
-
BB-025
Reversal agent for BB-031
- DRUG
-
BB-031
RNA aptamer
Sponsors & Collaborators
-
Basking Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
Chris Argent, MD · Scientia Clinical Research Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-05
- Primary Completion
- 2026-03-18
- Completion
- 2026-03-18
Countries
- Australia
Study Locations
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