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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-A1 in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05136053
Recruitment Status : Not yet recruiting
First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
AprilBio Co., Ltd.

Brief Summary:

This clinical trial will be the FIH study of APB-A1. The study is intended to collect data on APB-A1 in order to support further development of this compound as a useful clinical candidate.

This study will establish safety and tolerability profiles for APB-A1 and will allow identification of recommended dose levels and dose intervals in subsequent studies.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Biological: Placebo Biological: APB-A1 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, 2-part,
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: PI and clinical staff are blinded to the treatment; however safety review of clinical laboratories including white blood cells count will be done real-time. These results may have potential to show pharmacologic effect, but treatment will not be unblinded unless needed for safety reasons.
Primary Purpose: Basic Science
Official Title: A Phase 1, 2-Part, Single Ascending Dose, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-A1 in Healthy Adult Subjects
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Active
Subjects will receive APB-A1
Biological: APB-A1
fusion protein developed by AprilBio

Placebo Comparator: Placebo
Subjects will receive placebo
Biological: Placebo
5 % Dextrose Water




Primary Outcome Measures :
  1. Number and severity of TEAEs [ Time Frame: 16 Weeks ]
    the safety and tolerability of single intravenous (IV) doses of APB A1 when administered to healthy adult subjects in Part A and Part B


Secondary Outcome Measures :
  1. AUC0-t [ Time Frame: 16 Weeks ]
    area under the concentration time curve, from time 0 to the last observed non-zero concentration of APB-A1

  2. AUC0-inf [ Time Frame: 16 Weeks ]
    area under the concentration time curve from time 0 extrapolated to infinity of APB-A1

  3. AUC%extrap [ Time Frame: 16 Weeks ]
    percent of AUC0-inf extrapolated of APB-A1

  4. Tmax [ Time Frame: 16 Weeks ]
    time to maximum observed concentration of APB-A1

  5. ADA detection [ Time Frame: 16 Weeks ]
    immunogenicity of single IV doses of APB A1 in healthy adult subjects in Part A and Part B

  6. TDAR (anti-KLH IgGand IgM titers). [ Time Frame: 16 Weeks ]
    PD effect of single IV doses of APB A1 on T cell dependent antibody response (TDAR) to KLH primary and secondary immunization in healthy adult subjects in Part B



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, adult, male or female* (of non childbearing potential only), 19-60 years of age, inclusive
  • Male subjects must follow protocol specified contraception guidance
  • Continuous non smoker who has not used nicotine containing products for at least 3 months prior to Day 1
  • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 and weight between 50 and 125 kg (inclusive)

Exclusion Criteria:

  • History or presence of alcohol or drug abuse within the past 2 years prior to Day 1.
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds (e.g., monoclonal antibodies).
  • History or presence of tuberculosis infection or positive QuantiFERON®-TB result at the screening visit.
  • History of disease(s) of the immune system function.
  • Received any vaccination in the last 2 months prior to Day 1.
  • Positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  • Any immunosuppressing medications 2 months prior to Day 1 and throughout the study.
  • Participation in another clinical study with monoclonal antibody within 90 days or 5 half lives (whichever is longer) prior to Day 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136053


Contacts
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Contact: Aprilbio Co., ltd +82 70 4027 7611 avbcu@aprilbio.com

Locations
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United States, New Jersey
Frontage Clinical Services Inc.
Secaucus, New Jersey, United States, 07094
Contact: Frontage C, MD         
Sponsors and Collaborators
AprilBio Co., Ltd.
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Responsible Party: AprilBio Co., Ltd.
ClinicalTrials.gov Identifier: NCT05136053    
Other Study ID Numbers: APB-A1-101
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No