Healthy SubjectsPhase 1NCT07304791
This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of BEAM-103 in Healthy Subjects
A Phase 1 study testing BEAM-103 in people with Healthy Subjects and Healthy Participant Study, run by Beam Therapeutics Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this Phase I single ascending dose study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of BEAM-103 in healthy subjects between the ages of 18 and 55. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Healthy Participant Study
- What is being tested?
- BEAM-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2025to 29 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 to ≤55 years
- Body mass index (BMI) of 18.5 to 25 kg/m2
- Morning neutrophil count ≥2.6 × 109 cells/L for Black/African American subjects or ≥3.5 ×109 cells/L for Caucasian/Other subjects
- Baseline hemoglobin value of ≥14 g/dL for males and ≥12 g/dL for females
- Baseline platelet count of >150 × 109/L.
- Subjects must be in general good health without significant medical conditions (based on physical exam, electrocardiogram (ECG), and laboratory test results with no clinically significant deviations), per the investigator's assessment
Who cannot join
- Known hypersensitivity to any component of the investigational medicinal product (IMP).
- Participation in another clinical trial involving treatment with an investigational agent within 90 days of informed consent is prohibited.
- Positive serum pregnancy test or breastfeeding at screening (female participants).
- Live virus vaccination within 4 weeks prior to signing informed consent.
- Any severe or uncontrolled medical condition (eg. severe asthma or severe peanut allergy) that in the opinion of the investigator would put the subject at undue medical risk or impair the ability to interpret study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Study Site
London
Medical Information, +1 857-327-8641, clinicalinfo@beamtx.com
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BEAM-103 in Healthy Subjects
The purpose of this Phase I single ascending dose study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of BEAM-103 in healthy subjects between the ages of 18 and 55. The main questions the study aims to answer are:
- Safety and tolerability of BEAM-103
- The pharmacokinetic (PK) profile and pharmacodynamic (PD) characteristics of EAM-103
- The effect of BEAM-103 on hematologic parameters
- To assess the immunogenicity of BEAM-103
Read more
Researchers will determine and establish the therapeutic window of the antibody and select optimal doses for future trials in patients.
Subjects will:
- Be asked to participate in the study for a duration of 4-5 months total
- Be asked to sign informed consent
- Be assessed for eligibility
- Provide medical and medication history
- Receive a single intravenous infusion of BEAM-103 or placebo on study Day 1 according to their assigned cohort
- Be followed up to 4 months after infusion
- Conditions
- Healthy Subjects, Healthy Participant Study
- Being tested
- BEAM-103, Placebo Comparator
- Keywords
- ESCAPE, BEAM-103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEAM-103Drug
- BEAM-103 is a monoclonal antibody administered as a single intravenous dose
Placebo ComparatorDrug
- The matching placebo comparator is administered as a single intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| BEAM-103 Drug Product | Experimental | BEAM-103 is a monoclonal antibody that will be administered in single dose ascending dose cohorts as an intravenous infusion through the arm. Receives: Drug: BEAM-103 |
| Placebo | Placebo comparator | Normal Saline Solution will be administered as a matching place in single dose ascending dose cohorts as an intravenous infusion through the arm. Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of single ascending doses of BEAM-103
Incidence of treatment-emergent AEs, serious AEs, severe AEs, AEs related to BEAM-103
Measured: from enrollment to the end of study at 5 months
Secondary outcomes (8)
Change in Free Stem Cell Factor (SCF) in Peripheral Blood Over Time
Concentration of SCF in peripheral blood measured in nanograms per milliliter (mL)
Measured: from the start of treatment to the end of study at 5 months
Change in Tryptase Level in Peripheral Blood Over Time
Serum tryptase concentration measured in nanograms per milliliter (ng/mL)
Measured: from the start of treatment to the end of study at 5 months
Change in Reticulocyte Count in Peripheral Blood Over Time
Absolute reticulocyte count measured in cells per microliter (cells/µL)
Measured: From enrollment to end of study at 5 months
Change in Neutrophil Count in Peripheral Blood Over Time
Absolute neutrophil count measured in cells per microliter (cells/µL)
Measured: From enrollment to end of study at 5 months
Maximum Observed Plasma Concentration (Cmax)
Cmax will be calculated as the highest observed plasma/blood/serum concentration following drug administration
Measured: From enrollment to end of study at 5 months
Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)
AUClast will be calculated from time zero to the time of the last quantifiable concentration
Measured: From enrollment to end of study at 5 months
Area Under the Plasma Concentration-Time Curve to Infinity (AUC∞)
AUC∞ will be calculated as AUClast plus Clast divided by λz
Measured: From enrollment to end of study at 5 months
Terminal Elimination Half-Life (t½)
t½ will be estimated from the terminal elimination phase of the plasma concentration-time curve
Measured: From enrollment to end of study at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start27 Oct 2025
- Primary completion29 Jan 2026 (estimated)
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beam Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304791
- Sponsor's protocol ID
- BTX-103-001
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BEAM-103 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07304791
- Acronym / sponsor ID
- BTX-103-001
- Conditions
- Healthy Subjects, Healthy Participant Study
- Keywords
- ESCAPE, BEAM-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beam Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 29 Jan 2026 (estimated)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase I single ascending dose study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of BEAM-103 in healthy subjects between the ages of 18 and 55. The main questions the study aims to answer are:
- Safety and tolerability of BEAM-103
- The pharmacokinetic (PK) profile and pharmacodynamic (PD) characteristics of EAM-103
- The effect of BEAM-103 on hematologic parameters
- To assess the immunogenicity of BEAM-103
Researchers will determine and establish the therapeutic window of the antibody and select optimal doses for future trials in patients.
Subjects will:
- Be asked to participate in the study for a duration of 4-5 months total
- Be asked to sign informed consent
- Be assessed for eligibility
- Provide medical and medication history
- Receive a single intravenous infusion of BEAM-103 or placebo on study Day 1 according to their assigned cohort
- Be followed up to 4 months after infusion
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEAM-103 Drug Product | Experimental | Drug: BEAM-103BEAM-103 is a monoclonal antibody that will be administered in single dose ascending dose cohorts as an intravenous infusion through the arm. |
| Placebo | Placebo comparator | Drug: Placebo ComparatorNormal Saline Solution will be administered as a matching place in single dose ascending dose cohorts as an intravenous infusion through the arm. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages 18 to ≤55 years
- Body mass index (BMI) of 18.5 to 25 kg/m2
- Morning neutrophil count ≥2.6 × 109 cells/L for Black/African American subjects or ≥3.5 ×109 cells/L for Caucasian/Other subjects
- Baseline hemoglobin value of ≥14 g/dL for males and ≥12 g/dL for females
- Baseline platelet count of >150 × 109/L.
Key exclusion criteria (5 listed)
- Known hypersensitivity to any component of the investigational medicinal product (IMP).
- Participation in another clinical trial involving treatment with an investigational agent within 90 days of informed consent is prohibited.
- Positive serum pregnancy test or breastfeeding at screening (female participants).
- Live virus vaccination within 4 weeks prior to signing informed consent.
- Any severe or uncontrolled medical condition (eg. severe asthma or severe peanut allergy) that in the opinion of the investigator would put the subject at undue medical risk or impair the ability to interpret study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEAM-103• BEAM-103 is a monoclonal antibody administered as a single intravenous dose | Drug | BEAM-103 Drug Product |
| Placebo Comparator• The matching placebo comparator is administered as a single intravenous dose | Drug | Placebo |
Primary outcome
To determine the safety and tolerability of single ascending doses of BEAM-103
Time frame: from enrollment to the end of study at 5 months
Incidence of treatment-emergent AEs, serious AEs, severe AEs, AEs related to BEAM-103
8 secondary outcomes
Change in Free Stem Cell Factor (SCF) in Peripheral Blood Over Time
Time frame: from the start of treatment to the end of study at 5 months
Change in Tryptase Level in Peripheral Blood Over Time
Time frame: from the start of treatment to the end of study at 5 months
Change in Reticulocyte Count in Peripheral Blood Over Time
Time frame: From enrollment to end of study at 5 months
Change in Neutrophil Count in Peripheral Blood Over Time
Time frame: From enrollment to end of study at 5 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: From enrollment to end of study at 5 months
Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)
Time frame: From enrollment to end of study at 5 months
Area Under the Plasma Concentration-Time Curve to Infinity (AUC∞)
Time frame: From enrollment to end of study at 5 months
Terminal Elimination Half-Life (t½)
Time frame: From enrollment to end of study at 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BEAM-103 in people with Healthy Subjects and Healthy Participant Study, run by Beam Therapeutics Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and tolerability of single ascending doses of BEAM-103 (time frame: from enrollment to the end of study at 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.