NCT07815561

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started Aug 2026

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Aug 2026May 2027

Study Start

First participant enrolled

August 31, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

September 2, 2026

Last Update Submit

September 8, 2026

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of single ascending doses of SAB01

    To assess the safety and tolerability of single ascending doses of SAB01 administered via subcutaneous (SC) and intravenous (IV) infusion in healthy participants

    Day 1 through Day 113

Secondary Outcomes (12)

  • Plasma PK profile.

    Day 1 through Day 113

  • Plasma PK profile

    Day 1 through Day 113

  • Pharmacodynamic (PD) effects of SAB01

    Day 1 through Day 113

  • Absolute bioavailability

    Day 1 through Day 113

  • Plasma PK profile

    Day 1 through Day 113

  • +7 more secondary outcomes

Other Outcomes (1)

  • Exploratory: PK/PD relationship

    Day 1 through Day 113

Study Arms (13)

SC Cohort A1, SAB01 Dose Level 1

EXPERIMENTAL

A total of 6 participants will receive a single SC administration of SAB01 at DL1.

Drug: Subcutaneous (SC) single dose of SAB01

SC Cohort A2, SAB01 Dose Level 2

EXPERIMENTAL

A total of 6 participants will receive a single SC administration of SAB01 at DL 2.

Drug: Subcutaneous (SC) single dose of SAB01

SC Cohort A3, SAB01 Dose Level 3

EXPERIMENTAL

A total of 6 participants will receive a single SC administration of SAB01 at DL 3.

Drug: Subcutaneous (SC) single dose of SAB01

SC Cohort A4, SAB01 Dose Level 4

EXPERIMENTAL

A total of 6 participants will receive a single SC administration of SAB01 at DL 4.

Drug: Subcutaneous (SC) single dose of SAB01

SC Cohort A5, SAB01 Dose Level 5

EXPERIMENTAL

A total of 6 participants will receive a single SC administration of SAB01 at DL 5.

Drug: Subcutaneous (SC) single dose of SAB01

SC Cohort A6, SAB01 Dose Level 6

EXPERIMENTAL

A total of 6 participants will receive a single SC administration of SAB01 at DL 6.

Drug: Subcutaneous (SC) single dose of SAB01

IV Cohort A10, SAB01

EXPERIMENTAL

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.

Drug: Intravenous (IV) infusion of SAB01

SC Placebo

PLACEBO COMPARATOR

A total of 12 participants will receive a single SC administration of placebo across the 6 planned SC cohorts.

Drug: Placebo SC

IV Placebo

PLACEBO COMPARATOR

A total of 2 participants will receive a single IV administration of placebo.

Drug: Placebo IV Infusion

Optional SC Cohort A7, SAB01

EXPERIMENTAL

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.

Drug: Subcutaneous (SC) single dose of SAB01

Optional SC Cohort A8, SAB01

EXPERIMENTAL

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.

Drug: Subcutaneous (SC) single dose of SAB01

Optional SC Cohort A9, SAB01

EXPERIMENTAL

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.

Drug: Subcutaneous (SC) single dose of SAB01

Optional IV Cohort A11, SAB01

EXPERIMENTAL

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.

Drug: Intravenous (IV) infusion of SAB01

Interventions

Subcutaneous (SC) single dose of SAB01DRUG

Single-dose administration of SAB01 by SC administration.

Optional SC Cohort A7, SAB01Optional SC Cohort A8, SAB01Optional SC Cohort A9, SAB01SC Cohort A1, SAB01 Dose Level 1SC Cohort A2, SAB01 Dose Level 2SC Cohort A3, SAB01 Dose Level 3SC Cohort A4, SAB01 Dose Level 4SC Cohort A5, SAB01 Dose Level 5SC Cohort A6, SAB01 Dose Level 6
Intravenous (IV) infusion of SAB01DRUG

Intravenous doses of SAB01 via IV infusion.

IV Cohort A10, SAB01Optional IV Cohort A11, SAB01
Placebo SCDRUG

Single-dose of placebo by subcutaneous (SC) administration.

SC Placebo
Placebo IV InfusionDRUG

Placebo administration via IV infusion.

IV Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed and dated ICF.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Healthy adult male or female aged at least 18 years but not older than 55 years.
  • Body mass index (BMI) within 18.0 to 32.0 kg/m2 inclusive, and up to a maximum body weight of 100 kg at Screening.
  • Non- or ex smokers. Participants must not have used any tobacco products within 6 months prior to Screening. Participants who have discontinued smoking or the use of nicotine or nicotine-containing products for at least 3 months prior to Screening may be enrolled at the discretion of the Investigator
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by an Investigator
  • Have clinical laboratory values within the normal range or, if abnormal, deemed not clinically significant by the Investigator (following consultation with the Sponsor, as appropriate).
  • Serum tryptase levels within clinically accepted normal ranges (ie, ≥ 1.4 to ≤11.5 µg/L) at Screening.

You may not qualify if:

  • Female who is breastfeeding or is pregnant according to the pregnancy test at Screening or on Day -1, or is planning to become pregnant any time during the study and for 8 months after study drug administration.
  • Body temperature ≥ 38°C/100.4 F or symptomatic viral or bacterial infection within 2 weeks prior to Screening, or active or acute infection requiring systemic antibiotic treatment (oral or IV) within 4 weeks prior to Screening.
  • History of clinically significant anaphylaxis, food allergies, asthma, or allergies (chronic or seasonal) requiring medication, as determined by an Investigator.
  • Known or suspected intolerance to SAB01 or any related products (including excipients of the formulations).
  • History of clinically significant diseases within 5 years prior to study drug administration.
  • Clinically significant illness within 4 weeks of study drug administration.
  • Previous or concurrent malignancy with the following exceptions:
  • Adequately treated basal cell or squamous cell carcinoma,
  • In situ carcinoma of the uterine cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to Screening.
  • History of alcohol or drug abuse (within 1 year of Screening).
  • History of benign neutropenia and/or an absolute neutrophil count of \< 2.0 × 109/L or 2.0 × 103/µL at Screening or on Day -1.
  • Use of any prescription drugs (with the exception of hormonal contraceptives or hormonal replacement therapy), over-the-counter (OTC) medications, vitamins, herbal medicines (including St. John's wort) or cannabis within 7 days or 5 half-lives (whichever is longer) prior to study drug administration, that in the opinion of an Investigator would put into question the status of the participant as healthy. Acetaminophen is permitted provided the total daily dose does not exceed 2 g per day.
  • Consumption of \> 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine).
  • Currently enrolled in another investigational drug or device study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) have passed since completion of another investigational drug or device study; or plans to enroll in another investigational drug or device study during participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Altasciences LA

Cypress, California, 90630, United States

NOT YET RECRUITING

Altasciences Company Inc - Clinical Research Unit

Mount Royal, Quebec, H3P 3P1, Canada

RECRUITING

MeSH Terms

Interventions

Injections, Subcutaneous

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 11, 2026

Study Start

August 31, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 11, 2026

Record last verified: 2026-09

Locations

US(1)CA(1)