To Assess Safety, Tolerability and PK of NEX-20A, a Subcutaneous Prolonged-release Injection to Healthy Subjects

NCT05643248 | Completed Early Phase 1 DMC

• 1 other identifier: NEX-20-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, single ascending dose (SAD) pilot study designed to evaluate the safety, tolerability, including local tolerability, and pharmacokinetics (PK) of NEX-20A (lenalidomide) after the administration of a single subcutaneous prolonged-release injection to healthy male volunteers

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (27)

• Number of subjects with a clinical significant change from baseline in the systolic blood pressure at 36 days

  Measured in mmHg after 10 minutes supine rest. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the diastolic blood pressure at 36 days

  Measured in mmHg after 10 minutes supine rest. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR at 36 days

  Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the ECG parameter QRS at 36 days

  Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the ECG parameter QT at 36 days

  Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the ECG parameter QTcF at 36 days

  Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the haematology blood parameters measurements at 36 days

  Blood samples for the analysis of haematology will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the clinical chemistry blood laboratory measurements at 36 days

  Blood samples for the analysis of clinical chemistry parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the coagulation parameters blood laboratory measurements at 36 days

  Blood samples for the analysis of clinical coagulation parameters will be collected through venpuncture or an indwelling venous catheter. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the head at 36 days

  Physical examination including assessment of the head. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of eyes at 36 days

  Physical examination including assessment of the eyes. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the ears at 36 days

  Physical examination including assessment of the ears.Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the nose at 36 days

  Physical examination including assessment of the nose.Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the throat at 36 days

  Physical examination including assessment of the throat. .Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the skin at 36 days

  Physical examination including assessment of the skin. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the thyroid at 36 days

  Physical examination including assessment of the thyroid. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of neurological status at 36 days

  Physical examination including neurological status. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the lungs at 36 days

  Physical examination of the lungs including percussion, inspection, palpation, and auscultation.Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the cardiovascular status of at 36 days

  Physical examination including inspection, palpation, and auscultation of the heart. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of the abdomen at 36 days

  Physical examination including assessments of the abdomen (liver and spleen). Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of lymph nodes at 36 days

  Physical examination including assessments of the lymph nodes. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in the physical examination of extremitets at 36 days

  Physical examination including assessments of the extremitets. Descriptive individual data.

  From first dose until day 36

• Number of subjects with treatment-related adverse events a assessed by frequency

  Number of events.Descriptive individual data.

  From first dose until day 36

• Number of subjects with treatment-related adverse events a assessed by seriousness

  Seriousness of adverse events.Descriptive individual data.

  From first dose until day 36

• Number of subjects with treatment-related adverse events a assessed by intensity

  Intensity of adverse events.Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by visual inspection.

  Visual inspection. Descriptive individual data.

  From first dose until day 36

• Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by photography.

  Photography of injection site. Descriptive individual data.

  From first dose until day 36

Secondary Outcomes (7)

• Maximum observed plasma concentration (Cmax)

  pre-dose and at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours post-dose on Day 1, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 408 hours, 504 hours, 576 hours, 672 hours, 744 hours, 840 hours

• Time of occurrence of Cmax (Tmax)

  pre-dose and at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours post-dose on Day 1, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 408 hours, 504 hours, 576 hours, 672 hours, 744 hours, 840 hours

• Area under the plasma concentration vs. time curve (AUC) from time 0 to 8 hours

  pre-dose and at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours post-dose on Day 1, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 408 hours, 504 hours, 576 hours, 672 hours, 744 hours, 840 hours

• AUC from time 0 to 12 hours

  pre-dose and at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours post-dose on Day 1, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 408 hours, 504 hours, 576 hours, 672 hours, 744 hours, 840 hours

• AUC from time 0 to 7 days

  pre-dose and at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours post-dose on Day 1, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 408 hours, 504 hours, 576 hours, 672 hours, 744 hours, 840 hours

Study Arms (3)

Cohort 1

EXPERIMENTAL

The planned doses are 15 mg for the sentinel subject in cohort 1 and 35 mg for the remaining 2 subjects in cohort 1

Drug: NEX-20A

Cohort 2

EXPERIMENTAL

The planned dose for all 3 subjects in cohort 2 is 70 mg.

Drug: NEX-20A

Cohort 3

EXPERIMENTAL

The planned dose for all 3 subjects in the optional cohort 3 is 100 mg.

Drug: NEX-20A

Interventions

NEX-20A DRUG

Subcutaneous prolonged-release injection

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

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

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Healthy male subject aged 18 to 65 years, inclusive.
• Clinically normal medical/surgical history, physical findings, vital signs, 12-lead electrocardiograms (ECGs) and safety laboratory values at the time of screening, as judged by the Investigator.
• Prospective (male) subjects who are sexually active with female partners must agree to use condoms as well as one of the following highly effective (failure rate \<1%) methods of contraception with their partner(s) from 14 days prior to the time of NEX-20A administration until 90 days after the follow-up/end-of-study visit (Visit 14).
• Previous male sterilization, defined as vasectomy conducted at least 6 months prior to screening with appropriate post-vasectomy documentation of the absence of sperm cells in the ejaculate.
• Previous female sterilization, defined as tubal ligation or permanent bilateral occlusion of fallopian tubes.
• Oral (except low-dose gestagen \[lynestrenol and norethisterone\]), injectable or implanted hormonal contraceptive associated with the inhibition of ovulation.
• Intrauterine device (IUD).
• Intrauterine hormone-releasing system (IUS), e.g., progestin-releasing coil

You may not qualify if:

• Body weight outside body mass index 18-30 kg/m2
• Subjects who intend to father a child during the course of the study, i.e., from screening to the final pregnancy check at Visit 15, or whose female partner is pregnant or currently breastfeeding.
• Regular smoking or use of nicotine products within the past 6 months prior to screening.
• Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times/week before the screening visit will be allowed.
• Any intake of alcohol within the previous 24 hours of screening or subsequent study visits, according to alcohol urine tests.
• Any positive screen for drugs of abuse at screening or subsequent study visits.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV), according to diagnostic tests.
• Any use of prescription medication within the previous 14 days of the administration of NEX-20A, at the discretion of the Investigator.
• Any use of over the counter (non-prescription) medication within the previous 48 hours of the administration of NEX-20A, at the discretion of the Investigator, except occasional intake of paracetamol (maximum 2000 mg/day), as well as nasal decongestants without cortisone, antihistamine or anticholinergics.
• Regular use of any herbal remedies, vitamins, minerals, and other food supplements, at the discretion of the Investigator, within the previous 14 days of the administration of NEX-20A.
• Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
• Dermatological conditions, tattoos or large scars on the abdomen, thigh or upper arm which, in the opinion of the Investigator, may limit the evaluation of local tolerability.
• History of or current thromboembolic disease, including but not limited to deep vein thrombosis (DVT) and other venous thromboembolisms, untreated hypertension and/or untreated hyperlipidaemia, as judged by the Investigator.
• History of or current hematologic disorder, including but not limited to thrombocytopenia and/or neutropenia, as judged by the Investigator.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to lenalidomide or drugs with a similar chemical structure or class or to any other ingredient of the formulation/vehicle.

Sponsors & Collaborators

• Nanexa AB: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

CTC Clinical Research Consultants AB

Uppsala, Sweden

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hjalmar Flygt

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 8, 2022
• Study Start: November 28, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)