NCT07202663

Study of BB-025, Alone and After BB-031, in Healthy Volunteers

A Single Center, Two-part, Double-blind, Randomized, Placebo-controlled, Dose-escalation, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BB-025 or Placebo, Alone and Following a Single Dose of BB-031, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Basking Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	BB-025	Reversal agent for BB-031
DRUG	BB-031	RNA aptamer

Timeline

• Start date: 2025-11-05
• Primary completion: 2026-03-18
• Completion: 2026-03-18
• First posted: 2025-10-02
• Last updated: 2026-04-06

Locations

1 site across 1 country: Australia