Multiple MyelomaEarly Phase 1NCT05643248
To Assess Safety, Tolerability and PK of NEX-20A, a Subcutaneous Prolonged-release Injection to Healthy Subjects
A Early Phase 1 study testing NEX-20A in people with Multiple Myeloma, run by Nanexa AB at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- NEX-20A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSweden
- Study dates
- 28 Nov 2022to 26 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- Family history of thromboembolic disease, specifically first-degree relative with history of or current thromboembolic disease (see exclusion criterion 12), 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.
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the treatment visit (Visit 2).
- Any planned major surgery within the duration of the study.
- After 10 minutes supine rest at the time of screening, any vital signs outside the following ranges:
- Systolic blood pressure: <90 or >140 mmHg, or
- Diastolic blood pressure <50 or >90 mmHg, or
- Pulse <40 or >90 bpm
- Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- Bilirubin >25 µmol/L, alanine aminotransferase (ALT) >1.1 µkat/L, and/or aspartate aminotransferase (AST) >0.75 µkat/L at the time of screening (all values 1x upper limit of normal [ULN]).
- Estimated glomerular filtration rate (eGFR) <80 mL/min/1.73 m2 (determined from plasma creatinine by the revised Lund-Malmö GFR estimating equation) at the time of screening.
- Haemoglobin <130 g/L, absolute neutrophil count (ANC) <1.3x109/L, and/or platelet count <150x109/L at the time of screening.
- History of or current alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- History of or current drug abuse, as judged by the Investigator.
- History of or current use of anabolic steroids, as judged by the Investigator.
- Participation in any other clinical study and/or treatment with another investigational drug within 90 days of the treatment visit (Visit 2).
- Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 90 days prior to screening.
- Lack of suitability for participation in the study, for any reason, in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Ascending Dose Pilot Study to Assess the Safety, Tolerability and Pharmacokinetics of NEX-20A Given as a Subcutaneous Prolonged-release Injection to Healthy Male Subjects
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
Read the detailed description
NEX-20A will be administered in sequential cohorts, 2 standard cohorts and an optional third cohort, each comprising 3 subjects. Subjects will be dosed in a sentinel fashion, and all available safety and tolerability data up until and including 10 days for the sentinel subjects must have been evaluated by the iSRC before dosing the remaining 2 subjects in each cohort.Once safety, tolerability and PK data of the last subject in each cohort has been collected, and interim data analysis has been conducted, there must be at least 1 week between dose escalations.
- Conditions
- Multiple Myeloma
- Being tested
- NEX-20A
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEX-20ADrug
Subcutaneous prolonged-release injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: NEX-20A |
| Cohort 2 | Experimental | The planned dose for all 3 subjects in cohort 2 is 70 mg. Receives: Drug: NEX-20A |
| Cohort 3 | Experimental | The planned dose for all 3 subjects in the optional cohort 3 is 100 mg. Receives: Drug: NEX-20A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose until day 36
Number of subjects with treatment-related adverse events a assessed by frequency
Number of events.Descriptive individual data.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose until day 36
Secondary outcomes (7)
Maximum observed plasma concentration (Cmax)
Measurement of lenalidomid
Measured: 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)
Measurement of lenalidomid
Measured: 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
Measurement of lenalidomid
Measured: 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
Measurement of lenalidomid
Measured: 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
Measurement of lenalidomid
Measured: 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 infinity
Measurement of lenalidomid
Measured: 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
Terminal elimination half-life
Measurement of lenalidomid
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start28 Nov 2022
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanexa AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Hjalmar Flygt, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643248
- Sponsor's protocol ID
- NEX-20-01
- Status last verified
- Oct 2023
- First submitted
- 21 Nov 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Pilot Study to Assess the Safety, Tolerability and Pharmacokinetics of NEX-20A Given as a Subcutaneous Prolonged-release Injection to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05643248
- Acronym / sponsor ID
- NEX-20-01
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nanexa ABIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
NEX-20A will be administered in sequential cohorts, 2 standard cohorts and an optional third cohort, each comprising 3 subjects. Subjects will be dosed in a sentinel fashion, and all available safety and tolerability data up until and including 10 days for the sentinel subjects must have been evaluated by the iSRC before dosing the remaining 2 subjects in each cohort.Once safety, tolerability and PK data of the last subject in each cohort has been collected, and interim data analysis has been conducted, there must be at least 1 week between dose escalations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: NEX-20AThe planned doses are 15 mg for the sentinel subject in cohort 1 and 35 mg for the remaining 2 subjects in cohort 1 |
| Cohort 2 | Experimental | Drug: NEX-20AThe planned dose for all 3 subjects in cohort 2 is 70 mg. |
| Cohort 3 | Experimental | Drug: NEX-20AThe planned dose for all 3 subjects in the optional cohort 3 is 100 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEX-20ASubcutaneous prolonged-release injection | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of subjects with a clinical significant change from baseline in the systolic blood pressure at 36 days
Time frame: From first dose until day 36
Measured in mmHg after 10 minutes supine rest. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the diastolic blood pressure at 36 days
Time frame: From first dose until day 36
Measured in mmHg after 10 minutes supine rest. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR at 36 days
Time frame: From first dose until day 36
Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the ECG parameter QRS at 36 days
Time frame: From first dose until day 36
Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the ECG parameter QT at 36 days
Time frame: From first dose until day 36
Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the ECG parameter QTcF at 36 days
Time frame: From first dose until day 36
Measured in ms in supine position after 10 minutes of rest using an ECG machine. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the haematology blood parameters measurements at 36 days
Time frame: From first dose until day 36
Blood samples for the analysis of haematology will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the clinical chemistry blood laboratory measurements at 36 days
Time frame: From first dose until day 36
Blood samples for the analysis of clinical chemistry parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the coagulation parameters blood laboratory measurements at 36 days
Time frame: From first dose until day 36
Blood samples for the analysis of clinical coagulation parameters will be collected through venpuncture or an indwelling venous catheter. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the head at 36 days
Time frame: From first dose until day 36
Physical examination including assessment of the head. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of eyes at 36 days
Time frame: From first dose until day 36
Physical examination including assessment of the eyes. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the ears at 36 days
Time frame: From first dose until day 36
Physical examination including assessment of the ears.Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the nose at 36 days
Time frame: From first dose until day 36
Physical examination including assessment of the nose.Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the throat at 36 days
Time frame: From first dose until day 36
Physical examination including assessment of the throat. .Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the skin at 36 days
Time frame: From first dose until day 36
Physical examination including assessment of the skin. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the thyroid at 36 days
Time frame: From first dose until day 36
Physical examination including assessment of the thyroid. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of neurological status at 36 days
Time frame: From first dose until day 36
Physical examination including neurological status. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the lungs at 36 days
Time frame: From first dose until day 36
Physical examination of the lungs including percussion, inspection, palpation, and auscultation.Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the cardiovascular status of at 36 days
Time frame: From first dose until day 36
Physical examination including inspection, palpation, and auscultation of the heart. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of the abdomen at 36 days
Time frame: From first dose until day 36
Physical examination including assessments of the abdomen (liver and spleen). Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of lymph nodes at 36 days
Time frame: From first dose until day 36
Physical examination including assessments of the lymph nodes. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in the physical examination of extremitets at 36 days
Time frame: From first dose until day 36
Physical examination including assessments of the extremitets. Descriptive individual data.
Number of subjects with treatment-related adverse events a assessed by frequency
Time frame: From first dose until day 36
Number of events.Descriptive individual data.
Number of subjects with treatment-related adverse events a assessed by seriousness
Time frame: From first dose until day 36
Seriousness of adverse events.Descriptive individual data.
Number of subjects with treatment-related adverse events a assessed by intensity
Time frame: From first dose until day 36
Intensity of adverse events.Descriptive individual data.
Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by visual inspection.
Time frame: From first dose until day 36
Visual inspection. Descriptive individual data.
Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by photography.
Time frame: From first dose until day 36
Photography of injection site. Descriptive individual data.
7 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 infinity
Time frame: 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
Terminal elimination half-life
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hjalmar Flygt principal investigator
CTC Clinical Trial Consultants AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NEX-20A in people with Multiple Myeloma, run by Nanexa AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with a clinical significant change from baseline in the systolic blood pressure at 36 days (time frame: From first dose until day 36). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.