Safety and TolerabilityPhase 1NCT03853421
Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin
A Phase 1 study testing Sevuparin in people with Safety and Tolerability, run by Modus Therapeutics AB at 1 site in United States.
Trial summary
A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- Sevuparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 6 May 2019
- Phase
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent form is signed and dated
- Adult male or female subjects, aged ≥18 to ≤65 years of age inclusive;
- Body mass index ≥19.0 to ≤29.0 kg/m2 and a body weight 50.0-100.0 kg
- Subjects must have a negative pregnancy test and subjects of childbearing potential must either be surgically sterile or be willing to practice a highly effective method of contraception
- Subjects must be in good health, as determined by a medical history, physical examination
- Subjects with no clinically significant and relevant history that could affect the conduct of the study.
Who cannot join
- Recent trauma or injury or history of clinically significant bleeding.
- Clinical evidence of significant or unstable medical illness
- Subjects who have received any prescribed systemic or topical medication
- Subjects who have received aspirin, anti-platelet therapy, anticoagulant therapy and prophylactic and therapeutic LMWH or un-fractioned heparin.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies)
- Subjects who have received any medications known to chronically alter drug absorption or elimination processes
Show all 19Show fewer
- Subjects who are still participating in a clinical study
- Subjects who have donated any blood, plasma or platelets
- Subjects with a significant history of drug allergy
- Subjects who have any clinically significant allergic disease
- Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as QTcF interval > 470 ms, or with sinus rhythm with PR interval <110 ms or >210 ms, confirmed by a repeat ECG.
- Screening transaminases (AST, ALT, GGT) ≥ 1.5 times the ULN; estimated glomerular filtration rate (GFR, MDRD equation) < 60 mL/min; APTT above the normal range, INR above 1.4; absolute platelet count <150,000/μL.
- Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
- Subjects with a positive urine drug screen/alcohol test result
- Subjects who smoke more than 6 cigarettes
- Subjects who have positive hepatitis B or hepatitis C antibody or HIV antibodies.
- Subjects who test positive for HIT antibodies at Screening.
- Any relevant condition, behavior, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami (CPMI)
Miami, Florida, 33014
About this study
Official title: A Double-blind, Placebo-controlled Study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
Read the detailed description
This is a randomized, double-blind, placebo-controlled, sequential cohort, single escalating dose study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of sevuparin in healthy volunteer adult male and female subjects. The study will consist of three subcutaneous dose cohorts (3, 6 and 9 mg/kg sevuparin). Each dosing cohort will consist of 8 subjects who will be randomized to receive either a single dose of sevuparin or matching placebo in a 3:1 ratio (6 active/2 placebo).
- Conditions
- Safety and Tolerability
- Being tested
- Sevuparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevuparinDrug
The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Dose cohort 3 mg/kg sevuparin | Experimental | The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1. Receives: Drug: Sevuparin |
| Dose cohort 6 mg/kg sevuparin | Experimental | The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1. Receives: Drug: Sevuparin |
| Dose cohort 9 mg/kg sevuparin | Experimental | The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1. Receives: Drug: Sevuparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of single ascending subcutaneous doses of sevuparin in healthy male and female subjects.
Number of participants with treatment-related adverse events as assessed by CTCAE
Measured: From baseline until day 28
Secondary outcomes (2)
PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts).
Maximum Plasma Concentration [Cmax],
Measured: Pre dose until day 3
PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts).
Area Under the Curve [AUC]).
Measured: Pre dose until day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start6 Feb 2019
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modus Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853421
- Sponsor's protocol ID
- PKSC01
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
- ClinicalTrials.gov ID
- NCT03853421
- Acronym / sponsor ID
- PKSC01
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Modus Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 25 Feb 2019 (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.
A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
Detailed description
This is a randomized, double-blind, placebo-controlled, sequential cohort, single escalating dose study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of sevuparin in healthy volunteer adult male and female subjects. The study will consist of three subcutaneous dose cohorts (3, 6 and 9 mg/kg sevuparin). Each dosing cohort will consist of 8 subjects who will be randomized to receive either a single dose of sevuparin or matching placebo in a 3:1 ratio (6 active/2 placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
| Arm | Type | Receives |
|---|---|---|
| Dose cohort 3 mg/kg sevuparin | Experimental | Drug: SevuparinThe study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1. |
| Dose cohort 6 mg/kg sevuparin | Experimental | Drug: SevuparinThe study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1. |
| Dose cohort 9 mg/kg sevuparin | Experimental | Drug: SevuparinThe study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent form is signed and dated
- Adult male or female subjects, aged ≥18 to ≤65 years of age inclusive;
- Body mass index ≥19.0 to ≤29.0 kg/m2 and a body weight 50.0-100.0 kg
- Subjects must have a negative pregnancy test and subjects of childbearing potential must either be surgically sterile or be willing to practice a highly effective method of contraception
- Subjects must be in good health, as determined by a medical history, physical examination
Key exclusion criteria (19 listed)
- Recent trauma or injury or history of clinically significant bleeding.
- Clinical evidence of significant or unstable medical illness
- Subjects who have received any prescribed systemic or topical medication
- Subjects who have received aspirin, anti-platelet therapy, anticoagulant therapy and prophylactic and therapeutic LMWH or un-fractioned heparin.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies)
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 |
|---|---|---|
| SevuparinThe study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1. | Drug | Dose cohort 3 mg/kg sevuparin, Dose cohort 6 mg/kg sevuparin, Dose cohort 9 mg/kg sevuparin |
Primary outcome
To determine the safety and tolerability of single ascending subcutaneous doses of sevuparin in healthy male and female subjects.
Time frame: From baseline until day 28
Number of participants with treatment-related adverse events as assessed by CTCAE
2 secondary outcomes
PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts).
Time frame: Pre dose until day 3
PK characteristics of sevuparin during and after administration of sevuparin as a single subcutanous injection (3 dose co-horts).
Time frame: Pre dose until day 3
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 16 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sevuparin in people with Safety and Tolerability, run by Modus Therapeutics AB at 1 site in United States.
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 6 inclusion and 19 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 16 Jul 2019. 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 United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine the safety and tolerability of single ascending subcutaneous doses of sevuparin in healthy male and female subjects. (time frame: From baseline until day 28). 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 16 Jul 2019.