SAB01 for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
SAB01 is an investigational bispecific monoclonal antibody targeting mast cells. This first-in-human Phase 1 clinical trial evaluates the safety, pharmacokinetics, and pharmacodynamics of single ascending doses of SAB01 in healthy adult participants.
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants must meet general health requirements and cannot join if they have certain illnesses or risk factors as determined by the study team.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- SAB01
Trial Overview
The study is testing different single doses of a new antibody drug called SAB01, given either through an IV infusion or under the skin. Some participants will receive a placebo instead. The main goal is to check safety and how the body processes the drug.
How Is the Trial Designed?
13
Treatment groups
Experimental Treatment
Placebo Group
A total of 6 participants will receive a single SC administration of SAB01 at DL 6.
A total of 6 participants will receive a single SC administration of SAB01 at DL 5.
A total of 6 participants will receive a single SC administration of SAB01 at DL 4.
A total of 6 participants will receive a single SC administration of SAB01 at DL 3.
A total of 6 participants will receive a single SC administration of SAB01 at DL 2.
A total of 6 participants will receive a single SC administration of SAB01 at DL1.
A total of 6 participants may receive a single SC administration of SAB01 at a dose selected based on emerging safety, PK, and PD data.
A total of 6 participants may receive a single SC administration of SAB01 at a dose selected based on emerging safety, PK, and PD data.
A total of 6 participants may receive a single SC administration of SAB01 at a dose selected based on emerging safety, PK, and PD data.
A total of 6 participants may receive a single IV administration of SAB01 at a dose not exceeding a dose level previously evaluated by SC administration.
A total of 6 participants will receive a single IV administration of SAB01 at a dose level not exceeding a dose previously evaluated by SC administration.
A total of 12 participants will receive a single SC administration of placebo across the 6 planned SC cohorts.
A total of 2 participants will receive a single IV administration of placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Santa Ana Bio
Lead Sponsor
Altasciences Company Inc.
Industry Sponsor
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