Phase 1 Study Involving SAB01 and Healthy Participants

Part of paid clinical trials in Cypress, California.

Sponsor
Santa Ana Bio
Study ID
NCT07815561
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Subcutaneous (SC) single dose of SAB01 — DRUG
    Single-dose administration of SAB01 by SC administration.
  • Intravenous (IV) infusion of SAB01 — DRUG
    Intravenous doses of SAB01 via IV infusion.
  • Placebo SC — DRUG
    Single-dose of placebo by subcutaneous (SC) administration.
  • Placebo IV Infusion — DRUG
    Placebo administration via IV infusion.

Study Details

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.

Key Dates

First listed
Sep 11, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: SC Cohort A1, SAB01 Dose Level 1
    A total of 6 participants will receive a single SC administration of SAB01 at DL1.
  • Experimental: SC Cohort A2, SAB01 Dose Level 2
    A total of 6 participants will receive a single SC administration of SAB01 at DL 2.
  • Experimental: SC Cohort A3, SAB01 Dose Level 3
    A total of 6 participants will receive a single SC administration of SAB01 at DL 3.
  • Experimental: SC Cohort A4, SAB01 Dose Level 4
    A total of 6 participants will receive a single SC administration of SAB01 at DL 4.
  • Experimental: SC Cohort A5, SAB01 Dose Level 5
    A total of 6 participants will receive a single SC administration of SAB01 at DL 5.
  • Experimental: SC Cohort A6, SAB01 Dose Level 6
    A total of 6 participants will receive a single SC administration of SAB01 at DL 6.
  • Experimental: IV Cohort A10, SAB01
    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.
  • Placebo Comparator: SC Placebo
    A total of 12 participants will receive a single SC administration of placebo across the 6 planned SC cohorts.
  • Placebo Comparator: IV Placebo
    A total of 2 participants will receive a single IV administration of placebo.
  • Experimental: Optional SC Cohort A7, SAB01
    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.
  • Experimental: Optional SC Cohort A8, SAB01
    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.
  • Experimental: Optional SC Cohort A9, SAB01
    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.
  • Experimental: Optional IV Cohort A11, SAB01
    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.

Primary Outcome Measure

Safety and tolerability of single ascending doses of SAB01 [ Time Frame: Day 1 through Day 113 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences LACypressCalifornia90630
David Nguyen, M.D.
[email protected]
866-461-2526
David Nguyen, M.D. (PRINCIPAL_INVESTIGATOR)

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Altasciences LA· Cypress, CA

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