AzTrials
AzTrials

Healthy VolunteersPhase 1NCT07108894

A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants

A Phase 1 study testing ABCL575 in people with Healthy Volunteers, run by AbCellera Biologics Inc. at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
ABCL575
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
25 Jul 2025to Apr 2027
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male or female ≥ 18 and ≤ 65 years of age at the time of screening
  • Good general health as determined through medical history and general physical examination
  • Body weight ≥ 50 and ≤ 100 Kg
  • Body mass index (BMI) between 18.5 kg/m2 and 30.0 kg/m2
  • Non- or ex-smoker (an ex-smoker defined as someone who has completely stopped using nicotine products for at least 180 days prior to study drug administration)
  • Meeting 1 of the following:
Show all 9Show fewer
  • Is of childbearing potential or able to procreate and agrees to use an acceptable contraceptive method from the time of signing the ICF through the EOS visit.
  • Is of nonchildbearing potential or unable to procreate
  • If male, agrees not to donate sperm from the study drug administration through EOS visit; If female, agrees not to donate or retrieve eggs from the study drug administration through EOS visit

Who cannot join

  • Pregnancy and/or lactation.
  • Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or a seated blood pressure < 90/50 mmHg or > 140/90 mmHg
  • eGFR < 60 mL/min/1.73 m2
  • Severe hypersensitivity reactions (like angioedema) to any drugs.
  • Presence or history of significant gastrointestinal, liver disease, kidney disease, or surgery that may affect drug bioavailability.
  • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
Show all 15Show fewer
  • History or presence of multiple or severe drug allergies.
  • Evidence of any active bacterial, viral, or fungal infection
  • Disrupted skin integrity (apparent burn or dermatitis).
  • History of syncope, palpitations, or unexplained dizziness.
  • Use of prescription drugs (except for hormonal contraceptives or hormone replacement therapy) in the 28 days prior to study drug administration, that in the opinion of an investigator would put into question the participant's healthy status.
  • Use of any over-the-counter products in the 7 days or 5 half-lives (whichever is longer) prior to study drug administration.
  • Receipt of live vaccines within 5 weeks prior to screening or plans to receive live vaccines within 180 days after study drug administration.
  • History of latent or active tuberculosis.
  • History of herpes zoster (shingles) or RZV (eg, Shingrix) vaccination within 28 days prior to screening or scheduled during the study period

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Altasciences Company Inc.

    Mount Royal, Quebec, H3P 3P1

Other trials in Canada

About this study

This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo

Read the detailed description

This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 5 planned cohorts (A1 to A5), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A5.

Being tested
ABCL575, Placebo (Normal Saline 0.9%)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABCL575Biological

    Participants will receive SC injection of ABCL575

  • Placebo (Normal Saline 0.9%)Biological

    Participants will receive SC injection of placebo (Normal Saline 0.9%)

Study groups in NCT07108894
Study groupRoleWhat they receive
ABCL575ExperimentalHealthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection
Receives: Biological: ABCL575
PlaceboPlacebo comparatorHealthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection
Receives: Biological: Placebo (Normal Saline 0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, frequency, and severity of adverse events (AEs)

    Measured: Day 0 to day 337

  2. Changes from baseline in laboratory parameters including general biochemistry, lipid profile, coagulation, hematology, and urinalysis

    Measured: Day 0 to day 337

  3. Changes from baseline in physical examination

    Measured: Day 0 to day 337

  4. Changes from baseline in vital signs

    Measured: Day 0 to day 337

  5. Changes from baseline in 12-lead safety ECGs

    Measured: Day 0 to day 337

  6. Incidence and severity of injection site reactions

    Measured: Day 0 to day 337

Secondary outcomes (11)

  1. Plasma concentrations of ABCL575

    Measured: Day 0 to day 337

  2. Incidence of anti-ABCL575 antibodies

    Measured: Day 0 to day 337

  3. PK parameters; maximum plasma concentration (Cmax)

    Measured: Day 0 to day 337

  4. PK parameters; time to maximum plasma concentration (Tmax)

    Measured: Day 0 to day 337

  5. PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T)

    Measured: Day 0 to day 337

  6. PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)

    Measured: Day 0 to day 337

  7. PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)

    Measured: Day 0 to day 337

  8. PK parameters; terminal rate constant (λz)

    Measured: Day 0 to day 337

  9. PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)

    Measured: Day 0 to day 337

  10. PK parameters; apparent volume of distribution after extravascular administration (Vz/F)

    Measured: Day 0 to day 337

  11. PK parameters; half-life (Thalf)

    Measured: Day 0 to day 337

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start25 Jul 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108894
Sponsor's protocol ID
ABCL575-101
Other IDs
297628
Status last verified
Jul 2025
First submitted
24 Jul 2025
Last updated
16 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABCL575 in people with Healthy Volunteers, run by AbCellera Biologics Inc. at 1 site in Canada.

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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. 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 Canada. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, frequency, and severity of adverse events (AEs) (time frame: Day 0 to day 337). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07108894.

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 16 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in