A First-in-Human Study to Assess Single Doses of APNmAb005 in Healthy Participants

NCT05344989 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: APNmAb005-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. the starting dose of APNmAb005 is 5 mg/kg and the anticipated doses for subsequent cohorts are 10, 25, 50 and 70 mg/kg. A Safety Review Team (SRT) will review data on an ongoing basis throughout the study and before progression to the next dose level cohort. Subjects will receive a single dose of either APNmAb005 or placebo administered as a single IV infusion on Day 1 of the study and will remain in the study center until Day 3 (48 hours after dosing). They will return to the study center for 7 outpatient visits. The duration of the study, excluding screening, is approximately 71 days.

Conditions

Healthy Volunteers; Tauopathies; Alzheimer Disease

Keywords

Healthy Volunteers; Alzheimer's Disease; Alzheimer Disease; AD; Tauopathies; Tau

Outcome Measures

Primary Outcomes (7)

• Number of subjects with Adverse Events (AEs)

  Defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

  Day 70

• Number of subjects with Treatment-emergent AEs (TEAEs)

  Defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

  Day 70

• Number of subjects with Serious Adverse Events (SAEs)

  Defined as any AE for which there is a reasonable possibility that the study drug caused the AE. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

  Day 70

• Number of subjects with AEs resulting in Study Discontinuation

  Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

  Day 70

• Number of participants with Vital Sign Abnormalities

  Measured by systolic and diastolic blood pressures, pulse rate, respiratory rate and body temperature.

  Day 70

• Number of participants with Electrocardiogram (ECG) Abnormalities

  Measured by 12-lead ECG

  Day 70

• Number of participants with Clinical Laboratory Abnormalities

  Measured by hematology, coagulation, serum chemistry and urinalysis.

  Day 70

Secondary Outcomes (30)

• AUC0-t of APNmAb005 in plasma

  Thru Day 70

• AUC0-t of APNmAb005 in CSF

  Thru Day 14

• Cmax of APNmAb005 in blood

  Thru Day 70

• Cmax of APNmAb005 in CSF

  Thru Day 14

• Tmax of APNmAb005 in blood

  Thru Day 70

Study Arms (5)

APNmAb005 (5mg/kg) vs Placebo

ACTIVE COMPARATOR

Single Ascending Dose (SAD)

Drug: APNmAb005; Drug: Placebo

APNmAb005 (10 mg/kg) vs Placebo

ACTIVE COMPARATOR

Single Ascending Dose (SAD)

Drug: APNmAb005; Drug: Placebo

APNmAb005 (25 mg/kg) vs Placebo

ACTIVE COMPARATOR

Single Ascending Dose (SAD)

Drug: APNmAb005; Drug: Placebo

APNmAb005 (50 mg/kg) vs Placebo

ACTIVE COMPARATOR

Single Ascending Dose (SAD)

Drug: APNmAb005; Drug: Placebo

APNmAb005 (70 mg/kg) vs Placebo

ACTIVE COMPARATOR

Single Ascending Dose (SAD)

Drug: APNmAb005; Drug: Placebo

Interventions

APNmAb005 DRUG

Administered by IV infusion

APNmAb005 (10 mg/kg) vs Placebo; APNmAb005 (25 mg/kg) vs Placebo; APNmAb005 (50 mg/kg) vs Placebo; APNmAb005 (5mg/kg) vs Placebo; APNmAb005 (70 mg/kg) vs Placebo

Placebo DRUG

Administered by IV infusion

APNmAb005 (10 mg/kg) vs Placebo; APNmAb005 (25 mg/kg) vs Placebo; APNmAb005 (50 mg/kg) vs Placebo; APNmAb005 (5mg/kg) vs Placebo; APNmAb005 (70 mg/kg) vs Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) of 18.5 to 32 kg/m² inclusive, at screening.
• Female subjects of childbearing potential must use an acceptable method of birth control from screening until at least 90 days after study drug dosing; OR be surgically sterile; OR be postmenopausal. All female subjects must have a negative pregnancy test at screening and before the first dose of the study drug. Female subjects must also agree to refrain from egg donation during the study and for at least 90 days after study drug dosing.
• Male subjects must agree to use a condom when sexually active with a female partner of childbearing potential during the study and for at least 90 days after study drug dosing (or be surgically sterile); OR agree to practice abstinence during the study and for at least 90 days after study drug dosing. Male subjects must also agree to refrain from sperm donation during the study and for at least 90 days after study drug dosing.
• Agree to comply with all protocol requirements.
• Provide written informed consent.

You may not qualify if:

• Unable or unwilling to undergo venipuncture or tolerate venous access, or is unable or unwilling to undergo lumbar puncture.
• Has any significant acute or chronic medical illness that would impact the subject's ability to complete all study requirements or impact assessment of study data; or subject as had a clinically significant illness within 30 days prior to study drug dosing.
• Any medical condition or documented history that is a contraindication to lumbar puncture (e.g. bleeding disorder, spinal deformity).
• Positive COVID-19 molecular diagnostic test result at screening or prior to study drug dosing; or subject has known or suspected consequence from prior COVID-19 infection.
• History of cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or oncogenic (with the exception of resected skin basal cell carcinoma) disease within 5 years prior to screening).
• NOTE: Subjects with treated stable psychiatric conditions (e.g. anxiety, depression) are not allowed.
• Clinically significant neurological or psychiatric disorder.
• Major surgery, as determined by investigator, within 4 weeks prior to study drug dosing.
• Systolic blood pressure \>140 mm Hg and/or diastolic blood pressure \>90 mm Hg.
• Received any vaccine or used any prescription or over-the-counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days prior to study drug dosing.
• Consumed caffeine- or xanthine-containing products within 48 hours prior to study drug dosing.
• Subject is a smoker or has regularly used nicotine or nicotine-containing products (e.g. snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months prior to study drug dosing.
• Subject is involved in vigorous or strenuous physical activity or contact sports within 24 hours prior to study drug dosing.
• Subject has donated blood or blood products \>450 mL within 3 months prior to study drug dosing.

Sponsors & Collaborators

• APRINOIA Therapeutics, LLC: lead

Study Sites (1)

Collaborative Neuroscience Research, LLC., 2600 Redondo Ave.

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Tauopathies; Alzheimer Disease; Pick Disease of the Brain

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Study Officials

• Steven Reynolds, DO

  Collaborative Neuroscience Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: May 6, 2022
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)