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

AbCellera Biologics

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: Placebo (Normal Saline 0.9%); Biological: ABCL575

Study type: Interventional

Funder types: Industry

Identifiers

NCT07108894

297628 (Other Identifier)

ABCL575-101

Details and patient eligibility

About

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

Full description

This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 4 planned cohorts (A1 to A4), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A4.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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:

  1. Is of childbearing potential or able to procreate and agrees to use an acceptable contraceptive method from at least 28 days prior to the screening visit through EOS visit
  2. 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

Exclusion criteria

• 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.
• 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.
• Use of any over-the-counter products in the 7 days 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

ABCL575

Experimental group

Description:

Healthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection

Treatment:

Biological: ABCL575

Placebo

Placebo Comparator group

Description:

Healthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection

Treatment:

Biological: Placebo (Normal Saline 0.9%)