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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Single Doses of SBT115301 in Healthy Participants

NCT05388981

Safety

COMPLETED PHASE1

A First-in-Human Study With XAB05 in Healthy Subjects

NCT05307406

Infection, Bacterial

COMPLETED PHASE1

Phase 1a Single Ascending Dose Study of MIB-725 in Healthy Adults

NCT06815991

Healthy Adults

RECRUITING PHASE1

Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

NCT06048887

Healthy Volunteers

COMPLETED PHASE1

A Phase 1 Study of CLYM116 in Normal Healthy Volunteers

NCT07248865

Healthy Volunteers

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABCL575

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

Group Type EXPERIMENTAL

ABCL575

Intervention Type BIOLOGICAL

Participants will receive SC injection of ABCL575

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline 0.9%)

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABCL575

Participants will receive SC injection of ABCL575

Intervention Type BIOLOGICAL

Placebo (Normal Saline 0.9%)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes